This Dental Device Manufacturer Sets My Teeth on Edge

This week in Pedersen’s POV, our senior editor puts a contract manufacturer on blast.

Amanda Pedersen

May 20, 2024

3 Min Read
Graphic to accompany Pedersen's POV, a weekly opinion column exclusive to MD+DI.

Johns Dental’s ability to fly under FDA’s radar would almost be impressive – if it weren’t for the blatant disregard for patient safety.

A joint investigation by KFF Health News and CBS News uncovered that Johns Dental Laboratories manufactured the Anterior Growth Guidance Appliance (AGGA) for more than a decade without FDA inspection. Astonishingly, FDA became aware of the AGGA only after the investigative report, because Johns Dental never bothered to register the device.

The AGGA, also called the Osseo-Restoration Appliance, is promoted as a non-surgical method to remodel an adult’s jaw. Yet, patients suing Johns Dental report severe side effects, including flared teeth, damaged gums, and bone erosion.

The KFF Health News-CBS News report on Johns Dental published in March 2023. The news outlets recently published a follow up story on how the company managed to fly under FDA’s radar for so long.

Tipped off by the March 2023 news report, FDA investigator David Gasparovich showed up at Johns Dental in July 2023 for a surprise inspection. Five attorneys met him at the door and told employees not to answer any questions about the AGGA or the company's complaint policies. Despite this lack of cooperation, the FDA investigator issued seven citations against Johns Dental.

The inspection uncovered a serious lack of quality system management. In fact, the company had not even appointed anyone to oversee quality compliance. Also missing were procedures for corrective and preventive action, device history records, or for formally handling complaints.

Blame extends beyond Johns Dental. The device’s inventor, Steve Galella, a Tennessee dentist who trained other dentists on the procedure.

“It’s okay to make a crapload of money,” Galella told other dentists in training videos. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”

Whatever helps you sleep at night, Galella. Personally, I’d rather have a clean conscience than a “crapload of money.”

Galella’s confidence came, not from peer-reviewed evidence, but from years of using it on patients and unpublished dental scans.

“It proved it to me,” Galella said. “But for the rest of the world, I hadn’t posted anything. Sorry.”

That was apparently good enough for Johns Dental CEO Lisa Bendixen.

“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella’s specifications,” Bendixen said, according to a deposition transcript.

That’s hardly an excuse for the company’s flagrant disregard for quality control or patient safety though.

As Neil Di Spirito, a life sciences attorney, wrote in a recent LinkedIn post, the Federal Food, Drug, and Cosmetic Act and the Medical Device Amendments are often interpreted under a “know or should have known” criteria.

Johns Dental has reportedly responded to the FDA inspection with letters saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address the agency’s other concerns.

The AGGA case exposes a significant flaw in the regulatory system: FDA oversight relies heavily on manufacturers’ transparency. Without mandatory reporting, harmful devices can remain on the market unchecked. The controversy also questions FDA’s focus on dental devices. Historically, the agency appears more concerned with medical devices, a gap that must be closed to prevent future lapses in oversight.

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like