FDA Regulations of Customized Abutments
By: Gregg M. Gellman
As the Chief Executive Officer of Open Implants and new to blogging, I suddenly feel inspired and obligated to share what we have learned about the FDA. Specifically, I want to talk about their expectations with respect to the distribution and manufacturing of Ti-Base and Ti-Blank abutments.
As the digital wave took over the dental industry, we all knew it was inevitable that the FDA would become more involved in our everyday practices and have a tremendous impact on dental laboratories.
Some of you may not be aware that along with being more involved, the FDA now requires very specific wording and assurances in 510(k) submissions for companies that want to manufacture or distribute Ti-Bases and Ti-Blanks.
“FDA clearance!” What does this really mean?
To be clear, the FDA is responsible for protecting public health by regulating human drugs, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. However, not all those products undergo premarket review. That is, a review of safety and effectiveness or substantial equivalence by FDA experts and agency approval before a product can be marketed.
Thus, the FDA has three classifications for medical devices according to risk; they are Class I, Class II, and Class III. Devices that present a low risk of harm to the user (Class I) are subject to general controls only, and most are exempt from premarket notification requirements. For example, dental burs are considered a Class I device and do not require a 510k clearance.
However, moderate-risk, Class II devices such as dental implants require premarket clearance & high-risk. Class III devices such as heart valves require FDA premarket approval before being marketed by the manufacturer.
To receive FDA approval for Class III devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses. Generally, the FDA “clears” moderate-risk medical devices for marketing once demonstrated that the device is substantially equivalent to a legally marketed predicate device.
How does it directly impact my laboratory?
Conversely, the FDA does not “approve” health care facilities, laboratories, or manufacturers. BUT the FDA does have authority to inspect facilities producing regulated devices to verify that they are properly registered and comply with applicable good manufacturing practice (GMP) regulations. Technically, dental laboratories producing crowns and bridges are exempt from FDA establishment registration under regulation 29 CFR 807.65(i) but are still expected to follow GMP. However, the rise of CAD/CAM dentistry and the ability of dental laboratories to produce regulated dental implant abutments has changed the industry’s relationship with the FDA.
Titanium Bases and Titanium blanks are considered unfinished abutments by the FDA. Manufacturing and cementation of the top portion (mesostructure) of a titanium base abutment or milling of the titanium blank are the controlled manufacturing processes that convert the unfinished abutment to a finished medical device. When the FDA reviews a submission for dental implant abutments, they make sure systems are in place to control the manufacturing process.
So in order to legally market customized, finished implant abutments, a 510(k) clearance for the abutments is required. That clearance can be:
- On a complete design and manufacturing system, including materials and components, or
- On the raw abutment components provided an FDA-registered facility manufactures the final abutments according to the cleared component’s Indications for Use.
If your laboratory is marketing dental implant abutments, the abutments need to be produced under one of those two scenarios. Is that your laboratory? Or are you buying finished abutments which are produced in this manner?
How does this affect the longevity and sustainability of my laboratory?
Implant abutment 510k-holders are under increasing pressure from the FDA to restrict distribution and manufacturing paths for their products to follow the two scenarios above.
This will likely lead to fewer laboratories having access to raw Ti-bases and Ti-blank abutments.
If you look at a 510k Summary document, such as our recent one here:
https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212664.pdf
You will see language in the Indications for Use section which contains the words “sent to an Open-Implants validated milling center for manufacture.” This is FDA speak for scenario #2 above.
Are you prepared to buy a complete system with a 510k clearance to produce finished abutments?
Are you interested in becoming a validated milling center? This is one way to assure longevity and sustainability in this changing regulatory landscape.
What do I need to do?
Suppose you are interested in being a validated milling center. In that case, it involves developing, deploying, and following a Quality Management System (QMS) in operations, validation of manufacturing processes, and registration with the FDA.
A QMS will require documentation of training, processes, and maintenance of your production equipment. It will also require regular review of processes and outputs to ensure consistency. This generally leads to improved productivity, yield, and customer retention, which far outweigh the costs to implement the QMS in the first place.
Consider becoming a validated milling center. If that isn’t in the cards, talk to us about the validated milling centers you can work with!
You need to know! Ask the questions.
Is your abutment provider registered?
Is your abutment manufacturer providing you with FDA-cleared final finished abutments?
Will you be able to deliver FDA-cleared abutments to your doctors?
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