Thursday, October 17, 2019

Dentsply Sirona World 2019 proves again to be the dental industry’s must- attend educational event


As three days of unparalleled
educational opportunities and thrilling entertainment options
came to a close, attendees left the Mandalay Bay Resort and
Casino in Las Vegas understanding why Dentsply Sirona
World remains the premier dental event in the world.

“With more than 100 Breakout Sessions, rousing General
Sessions, top-tier entertainment and lively social activities,
Dentsply Sirona World proved why there is no equal to the
Ultimate Dental Meeting,” said Vice President of Marketing
Ingo Zimmer.

Held Oct. 3-5, attendees filled enlightening education sessions
taught by the biggest names in dentistry, got hands-on with
the most innovative technologies and products on the trade
show floor, experienced once-in-a-lifetime private shows from
the awarding-winning Zac Brown Band, iconic comedian Jerry
Seinfeld and so much more!

Continuing educational courses were offered in 12 specialized
tracks, a record for the event. Attendees had no shortage of
incredibly high-quality learning opportunities when they
personalized their schedules to meet their needs.

The General Sessions kept attendees on the edge of their
seats with inspiring speakers, including Dr. Mike Skramstad, Dr.
Rebecca Bockow, Imtiaz Manji, Dr. Shalin Shah, Amy Morgan,
Dr. Lyndon Cooper and one of the world’s top digital
strategists, Brendan Kane. Additionally, Dr. Meena Barsoum
and Dr. Tarun Agarwal performed live dental procedures.

Per usual, Dentsply Sirona World offered its guests the chance
to experience celebrity entertainment in a personal setting.
One of the top digital strategists in the world, Brendan Kane,
captivated the audience with this talk, sponsored by VITA,
during Friday’s general session, while legendary comedian
Jerry Seinfeld kept them laughing with his standup and the
crowd couldn’t stop dancing during the Grammy award
winning Zac Brown Band’s private concert.

Two wellness activities allowed attendees to better both their
minds and bodies, as Ivoclar Vivadent sponsored a pirate-
themed fun run and Solea sponsored a yoga class. Attendees
were in a jovial mood wearing their best pirate-inspired
costumes, as they made their way along the beautiful Las
Vegas Strip during Friday morning’s fun run. On Saturday,
guests looked inward and found their Zen during the Yoga
Session with Tara Jae.

The Bucca(l)neers’ Bash gathering was the perfect end to an
amazing three days in Las Vegas. Guests put on their eye
patches and hit the dance floor to socialize with their peers.
From the rousing band, to the tasty drinks and amazing pirate-
themed costumes, this party captured the true spirit of
Dentsply Sirona World.

Wednesday, October 16, 2019

The ADA’s Petition to FDA about SmileDirectClub is Still Active


Smile Direct Club is starting to take on water.  Take a look at this:

SmileDirectClub shares tumbled 13% on Monday, bringing their one-month loss to 46%, after California Gov. Gavin Newsom signed a bill into law that includes key changes in the regulation of the company’s “teledentistry” business model.  (MarketWatch)

Not to mention this headline:

SmileDirectClub is now the worst unicorn IPO of 2019, down nearly 60% from its debut (CNBC)

As Technology Evangelist, I am all about using tech to make the world, and especially health care, a better place.  However, I want it done *responsibly*, and from what I’ve gleaned about Smile Direct Club, it doesn’t meet that standard.

To make things worse for SDC (although worse is a relative term) the ADA (American Dental Association) has announced that they are also strongly opposed to the SDA model of treating patients.  To briefly summarize, SDC provides clear aligners with no physical exam from a doctor.  While in a few cases this might be feasible, I have seen many more cases in my career where a patient wants straighter teeth without realizing there are many factors that can compromise treatment.  Things such as active dental decay, periodontal disease, congenitally missing teeth, etc can greatly impact orthodontics and should be addressed and treated before even considering orthodontics.  

Here is the ADA’s latest announcement regarding this:

The American Dental Association (ADA) believes the public has a right to accurate information concerning the status of its pending  citizen petition submitted to the U.S. Food and Drug Administration (FDA) about SmileDirectClub, LLC’s direct-to-consumer plastic teeth aligner business. SmileDirectClub’s (SDC’s) inaccurate public statements that the ADA’s petition has been “shut down” or “dismissed” may deter customers who have experienced clinical problems in connection with SDC’s aligner “treatment therapy” from reporting their negative experiences to the FDA. 

SDC’s public misstatements, including in its Oct. 4 press release, are apparently based on a May 30, 2019 letter from the FDA to the ADA. The letter, which can be viewed at the citizen petition landing page, did not reject or dismiss any substantive aspect of the ADA’s citizen petition. The FDA’s letter explains:

“We appreciate the information [the ADA] provided. Such information is often helpful for us to identify problems with marketed products and possible violations of the laws and regulations that we enforce. We take complaints seriously and we will evaluate this matter to determine what follow-up action is appropriate.”

The letter further explains that the FDA does not initiate enforcement actions on behalf of petitioners. Instead, the FDA reviews the submitted evidence and decides for itself what action to take. All substantive issues raised by the ADA’s citizen petition remain fully before the FDA at this time. The comment period for the public to address the petition and for the ADA to supplement the petition is open until Oct. 22 at 11:59 pm.

Further proof of the continuing pendency of the ADA citizen petition is SDC’s acknowledgement of it in the “Risks Related to Legal and Regulatory Matters” section of SDC’s August 12, 2019 S-1 filing with the U.S. Securities and Exchange Commission. Had the FDA dismissed the ADA’s citizen petition, there would have been no reason for SDC to mention the petition in its securities filing, and certainly not to identify the regulatory proceeding as one of SDC’s existing “risks.” 

The ADA submitted its citizen petition and a complaint letter to the Federal Trade Commission’s (FTC) Bureau of Consumer Protection out of concern for public safety and customer recourse in the event of negative outcomes from SDC’s orthodontic “treatment therapy.” Plastic teeth aligners are designated by the FDA as a Class II medical device requiring a prescription. The ADA believes SDC is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction.

In lieu of having dentists review patient dental records or perform any sort of patient exam (whether using teledentistry or otherwise) before prescribing orthodontic treatment, SDC instead requires customers to self-report their dental condition. As the ADA explains in its citizen petition, customer self-reporting does not meet the applicable standard of care because it does not satisfy a dentist’s requisite professional due diligence. Put simply, SDC and the small number of “SDC-affiliated” dentists have no way of knowing whether a lay consumer’s self-reported dental condition is accurate, informed, or true in any respect. 

Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause bone loss, lost teeth, receding gums, bite problems, jaw pain, and other issues. Despite these potentially serious outcomes, SDC requires its customers to hold the company harmless from any negative consequences, as the ADA points out in its FDA citizen petition and FTC complaint letter.

In addition to these public health concerns, the ADA’s letter to the FTC cited various SDC practices the ADA believes to be deceptive under section 5 of the Federal Trade Commission Act, including:

Informing purchasers they have recourse against SDC via arbitration, when the same document includes a “small print” provision obligating the customer to waive any and all rights the customer “or any third party” may have against SmileDirectClub.

Soliciting customers by claiming that SDC aligners will correct their overbite, underbite, and crossbite conditions, or their “extreme” malocclusion. But after customers complain about poor clinical outcomes, SDC invokes other documents stating that its aligners cannot treat bite conditions at all and can only treat mild to moderate teeth misalignment, not “extreme” misalignment.

Claiming that SDC customers receive the same level of dental/orthodontic care as actual dental patients, when in fact SDC and its affiliated dentists provide virtually no care and, contrary to its claims, SDC does not use teledentistry.

The ADA considers it our public duty to make the relevant regulatory agencies aware of these facts, so those agencies can be fully informed and consider whatever actions they deem appropriate.

The FDA’s MedWatch voluntary reporting form may be used by both consumers and health care professionals to report poor clinical outcomes associated with medical devices, including plastic teeth aligners. The FTC also offers consumers an online form to report complaints about unfair and deceptive business practices on its website.

Tuesday, October 15, 2019

Ultradent Launches a VALO Curing Light into Space!!! And You Could Get a VALO for Only $0.99


There are some amazing things about Ultradent’s Valo curing light.  One of the most incredible is how durable it is.

The device is made out of aerospace grade aluminum which is the same aluminum used to make satellites, rockets, and missiles.  With that in mind, the smart and adventurous people at Ultradent had a great idea for the device’s 10 year anniversary.  That’s right, the first Valors hit the market in 2009.  To celebrate, they decided to actually launch a Valo into space!  Interested in seeing just how they did it? They have posted a video to FaceBook that shows the launch and even a brief “chase” by a drone.  

It’s not the easiest thing to do, getting something into space, but if something was easy, then the smart people at Ultradent wouldn’t do it!  I know these folks pretty well and I can say that those people love a good challenge.

So, they actually created a box carrying GoPro cameras, a Valo, and a bobble head of founder Dr Dan Fischer and attached the contraption to a weather balloon.  From the front lawn of Ultradent World Headquarters in South Jordan, Utah, the package was launched.  As you can see from the photo above, the project worked pretty well!  I do not know the final altitude that was achieved, but in the photo accompanying this post, you can see the curvature of the Earth.

Now if launching a curing light into space isn’t enough… the company has also announced a contest.  If you can guess where the Valo landed, you will be the proud owner of a Valo curing light for only 99¢!!!  That’s right, you can get the best curing light currently on the market for less than a buck.  Here is the link for the contest.  

Monday, October 14, 2019

Lung Injuries Due to Vaping Continue to be Reported


As almost everyone has heard, there has recently been a significant number of people afflicted with severe lung injuries apparently related to vaping.

While the exact cause is yet to be determined, it definitely appears to be caused by e-cigarettes.  The CDC (Center for Disease Control) has been investigating.  At this point, the CDC is strongly advising against using any of these products.  Now that the problems have come to the attention of federal agencies the investigations are progressing as fast as possible.

Here is what the CDC has stated as far as what they have so far determined:

  • As of October 8, 2019, 1,299* lung injury cases associated with the use of e-cigarette, or vaping, products have been reported to CDC from 49 states, the District of Columbia, and 1 U.S. territory.
  • Twenty-six deaths have been confirmed in 21 states.
  • All patients have reported a history of using e-cigarette, or vaping, products.
  • Most patients report a history of using tetrahydrocannabinol (THC)-containing products. The latest national and state findings suggest products containing THC, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers), are linked to most of the cases and play a major role in the outbreak.
  • Therefore, CDC recommends that you should not use e-cigarette, or vaping, products that contain THC.
  • Exclusive use of nicotine containing products has been reported by some patients with lung injury cases, and many patients with lung injury report combined use of THC- and nicotine-containing products. Therefore, the possibility that nicotine-containing products play a role in this outbreak cannot be excluded.
  • At present, CDC continues to recommend that people consider refraining from using e-cigarette, or vaping, products that contain nicotine.

Here is what is NOT known:

  • At this time, FDA and CDC have not identified the cause or causes of the lung injuries in these cases, and the only commonality among all cases is that patients report the use of e-cigarette, or vaping, products.
  • This outbreak might have more than one cause, and many different substances and product sources are still under investigation. The specific chemical exposure(s) causing lung injuries associated with e-cigarette product use, or vaping, remains unknown at this time.

Obviously the safest thing to do is to immediately discontinue use of e-cigarette products.  However, human nature being what it is, the practice will most likely continue for the foreseeable future.  If you or anyone you know uses e-cigarettes and experiences any symptoms, seek medical help immediately.

Thursday, October 10, 2019

Emsisoft Releases *FREE* Decryption Tool for Muhstik Ransomware


As we all know, having a strong and reliable antivirus program running on your computers is incredibly important.  Connecting to the Internet without a reliable antivirus is simply asking for trouble and not worth the risk.  However, many users simply opt for one of the “big boys” of antivirus and don’t even consider alternatives.

The problem with some of the more well known AV programs on the market  is that they are rather process intensive.  This means they can sometimes slow your system down considerably.  The good news is that you are protected, the bad news is that your computer takes considerably longer to accomplish tasks.  Some of these AV suites also insert themselves so deep into your system that trying to removed them is almost impossible.  That means if you ever decide to go with another company, you may be unable to uninstall the current program.

That’s why I recommend researching and evaluating multiple vendors and not simply going with a company because everyone has heard of them.  There are several companies that provide very strong and reliable AV protection for a lower cost and don’t take over your system.

Some of these companies were started by individuals with strong backgrounds in Internet security and they continue to do research into security problems and even offer solutions.  One of those companies is Emsisoft.  The company provides a very robust and reliable AV suite that is rock solid and affordable.

I also love the fact that the company is giving back to the security field.  As you know, a lot of my interests lately have been focused on security and trying to help readers avoid that ravages of Ransomware.  Emsisoft recently released a FREE decryption tool for the Ransomeware variant called “Muhstik”.  For those affected by it, short of paying the ransom those affected don’t have much choice.  However as a way to help those affected, Emsisoft released the software at no charge, simply because helping is the right thing to do.

If you’ve been affected by Muhstik this is great news.  For those of you looking for a terrific AV product and would like to support a company committed to helping the industry, take a look at Emsisoft.

Wednesday, October 9, 2019

New Mid-ClassProsthetic Teeth LineDelivers Unprecedented Blend of Aesthetics, Easy Handling , Versatilityand Value


Kulzer’s Delara universal tooth line represents a new go-to option for labs

Kulzer, a global leader in dental materials,has announced the launch of its Delara tooth line, which sets a new standard for mid-priced prosthetic teeth by delivering modern layering, natural aesthetics, and easy handling. Like Kulzer’s Mondial, Mondial i, Artic and Basic prosthetic tooth lines, and in keeping with the company’s long-standing tradition of in-depth cooperation with dental professionals, the Delara line was developed by dental technicians for dental technicians.

Coming to market in the fourth quarter of 2019, Delara features 16 VITA shades and2 bleach shades (BL2 andBL3) in an optimized portfolio to meet universal needs. Its unique surface structure allows for natural light shattering and provides modern shading,as opposed to the dull appearance of some prosthetic tooth lines. Due to its easy processing characteristics, even dental technicians who make corrections can rest assured that Delara’s aesthetics and lifelike effect will not be lost. The teeth provide for lively transparency and successfully manage to avoid the undesirable grayor yellowish effect that can occur in the mouth with other products.

One tooth line that meets virtually every need

In addition to being visually impressive, Delara teeth offer a natural feel and excellent functionality. Technicians will appreciate the easy processing, while lab owners will appreciate great versatility and value. Dental labs that use it as their go-to line of prosthetic teeth will find that they are able to complete the majority of their restoration work more efficiently –with less need for grinding to adjust the shape –while still delivering quality restorations.

Dental laboratories will appreciate Delara’s many benefits, including:
•Beautiful, lifelike aesthetics:Modern, bright shading, dynamic light refraction from the vivid surface structure and anatomical forms give Delara a vibrant and fresh appearance.
•Easy handling for enhanced productivity:Simple setup with a polishing buffer,a basal grinding reserve, optimized incisal edges and reduced cusps for easy interlock create added efficiency and predictability for busy labs.
•Versatility:Various setup possibilities (from tooth-to-tooth to cross bite), CAD/ CAM production for easy integration into digital workflows,and great functionality meanDelara delivers as a universal, go-to line of prosthetic teeth.
•Excellent value:Agreat price-to-performance ratio that sets a new standard for prosthetics in the mid-priced segment–all with Kulzer quality and the excellent durability and comfort that patients can enjoy for a lifetime.

Due to its easy processing characteristics, even dental technicians who make corrections can rest assured that Delara’s aesthetics and lifelike effect will not be lost,” said Obie Clifford , Kulzer Product Manager.“The teeth provide for lively transparency and successfully manage to avoid the undesirable gray or yellowish effect that can occur in the mouth with other products.”

A rich history of prosthetic tooth innovation

A manufacturer of dental acrylics since the 1930s,Kulzerhas developed a tradition of quality, reliability, excellent aesthetics and innovation unmatched within the field of dental prosthetics. The company is particularly renowned for its expertise in balancing optimal functionality with the highest aesthetics.Kulzer prides itself on listening closely and regularly to its customers in order to ensure that its products perform exactly as dental technicians, dentists and their patients expect. To that end, the company develops all of its denture products, including its new Delara line, in close collaboration with internal and external dental technicians.

Tuesday, October 8, 2019

Ransomware Forces California Medical Practice to Cease Operations


For the last couple of years now I’ve been preaching the benefits of security from my pulpit of Technology Evangelist.

Some of you have reached out to me via electronic means to tell me basically “Flucke, I’ve got this covered.  I don’t need the expense of an outside service to run my backups.”  Honestly, I get that.  If you are a real die hard techie type, perhaps you have adequate systems in place.  The problem with these situations is that it’s hard to really be *totally* sure you have all of the systems in place because it is hard to predict what problems you’ll face and how many backups you might need to overcome that situation.  That’s why I’ve always referred to backups as “a backup chain”.  Simply because you need as many links as possible and it’s hard to judge how many links you’ll need.  The golden rule is that you need “one more copy than you think you need”.

Today, let me tell you about a medical practice in California.  Wood Ranch Medical, located in Simi Valley, California suffered a Ransomware attack on August 10, 2019.  While not many details on the attack and the ensuing restoration efforts have become public, this much is known.  The attack immediately encrypted the servers, the patient records, and the backup hard drives.  Evidently over a month was spent trying to fix the problem to no avail.  On September 18, 2019 the practice announced on their website that they could not recover the data and with the backup drives also encrypted they cannot rebuild the medical records.  Basically every piece of data was lost.  Since there is no data left to run the business with, Wood Ranch announced they will be closing the practice permanently as of December 17, 2019.

You read that correctly.  The practice was so devastated by the RansomWare that they are ceasing operations and are closing.  Without being aware of all of the things that transpired behind the scenes, it is difficult to know exactly what happened and exactly how it happened.  Looking back on this situation now, I would be willing to wager that what seemed like an unneeded expense for professional backups now seems like a bargain to the practice.  It’s like that with a lot of things.  Sometimes the price seems high until you are actually faced with the prospect, and the costs, of recovering.

I do not receive a check from DDS Rescue & I want you to know that.  I recommend them because I use them, I believe in them, and I know that they would have been able to get this practice back up and running, perhaps in as little as ONE day.  The money spent for their service should be looked upon as insurance.  RansomWare has stolen a doctors dream from them.  Don’t let this happen to you.