Inside Dental Technology

December 2015, Volume 6, Issue 12

Published by AEGIS Communications

Are You Purchasing Illegal Abutments

As of November 2015, 14 dental milling centers and CAD/CAM titanium abutment blank suppliers (including some milling machine companies) are being investigated by the FDA for illegal abutment milling and distribution.

CAD/CAM customized abutments are classified as Medical Devices Level 2 by the FDA. In order to mill CAD/CAM customized abutments, the facility must have 510(k) clearance from the FDA or it is ILLEGAL (with the exception of authorized milling centers using all systems and materials from Sirona). Most of these illegal activities are done intentionally for personal gain with no regard for the law.

Some blank suppliers insist their products are FDA pending but, pre-marketing the CAD/CAM customized abutments before obtaining full 510(k) clearance is also ILLEGAL. Pending does not mean they are approved.

A common fallacy is that any lab can mill the CAD/CAM customized abutments as long as the titanium abutment blanks are FDA approved. Several companies insist they are distributing FDA approved blanks. At present time, there are no blanks by itself that are 510(k) cleared to mill as CAD/CAM customized abutments. Since the abutment becomes a medical device level 2 when using CAD/CAM technology to manufacture, the facility must acquire 510(k) clearance from the FDA. The FDA only permits dental technicians to hand mill customized abutments.

The reason the FDA have these regulations in the dental industry is to ensure the safety, efficacy and security of medical devices that are produced and marketed in the US. By having 510(k) clearance, the general public will trust our products when purchased. To produce medical devices level 1, 2 or 3, one must follow these rules and guidelines because it is the LAW. One should never support or enable these illegal activities.

By having 510(k) clearance in place, the manufacturer will minimize faulty production. Also, if anything goes wrong with these devices, manufacturers can locate where they came from and resolve the issues in a systematic manner. This essential process is an additional cost factor for having 510(k) clearance. The FDA has requested any illegal activities be reported directly to them. Please report illegal abutment production to:

Surveillance and Enforcement Branch II
FDA/CDRH/OC/DPLC
Building 66,
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

or submit to illegalabutments@creodental.com. The reported facilities will be submitted to the proper authorities at the FDA.


 

A MESSAGE FROM THE NADL

FDA Alert – Labs not permitted to use CAD/CAM for in-lab milling of most abutments
When FDA began studying the use of CAD/CAM in dental laboratory technology, the FDA’s initial focus was on angulation and the implant/abutment interface. FDA ultimately made clear statements that anyone making the implant/abutment interface is a “manufacturer” as such must obtain 510(k) clearance to do so. That still did not answer the questions about the “tooth end” of the abutment, the abutment collar/post. Sometime later FDA ultimately stated a dental laboratory may mill the collar/post as long as the dental laboratory follows the manufacturer’s FDA cleared instructions.

Now, nearly two years later, there is still only one manufacturer that has obtained FDA clearance for their in-lab CAD/CAM milling instructions for their abutment collar/post. FDA’s recent communications have alerted us to what this means for dental laboratories:
• With the exception of the abutments of the one manufacturer who has FDA cleared instructions*, dental laboratories may not CAD/CAM mill the abutment collar/post including the Ti-Base type “abutments blanks”.
• Abutment blanks may only be hand-milled.

Currently FDA enforcement efforts seem to primarily consist of sending compliance letters to manufacturers as their website marketing is brought to FDA’s attention.

*Sirona CAD/CAM System (K111421)

For More Information

Creodent Milling Center
P 888-803-4242
W creomc.com
E info@creomc.com
New York, NY