Illuminating FDA Requirements on Ti Bases and Blanks (Regulatory Standards CE)

Remember when laboratories were casting custom abutments and bars with UCLA abutments? The UCLA abutment was once the best solution for the most difficult cases, and they are still available. However, the onset of automated manufacturing and CAD/CAM dentistry has changed the industry, and more importantly, the industry's relationship with the Food and Drug Administration (FDA).

The FDA has not updated its written guidance but in 2017 began requiring new details in 510(k) submissions, specifically in the section for the manufacturer's 510(k) Indications for Use. A sample statement might be: "All digitally designed abutments and/or copings for use with the 510(k) Holder's branded CAD/CAM Abutments are intended to be sent to a validated milling center for manufacture."¹ The FDA's Implantable Dental Device Team's Acting Assistant Director, Andrew Steen, confirmed this requirement in a written communication to the author.

This may present cause for confusion in many laboratories. What is a validated milling center? How does a laboratory become a validated milling center? Unfortunately, the FDA has not provided, published, or made public any written guidance regarding this important operational change requirement for dental laboratories manufacturing CAD/CAM implant abutments.

In order to better understand the requirements, we must begin by dissecting that Indications for Use statement. First, look at the components included in the requirement.

Ti bases are used in most laboratories for implant-supported single crowns, bridges, and bars. Many dental laboratories are unaware of the FDA's validated milling center (VMC) requirement for incorporating Ti bases in their implant cases. To comply with this FDA requirement, laboratories must operate under a Quality System, and they must also register their establishment with the FDA as a contract manufacturer.² By the FDA's definition, a contract manufacturer is an establishment that manufactures a finished device to another establishment's specifications.³

The other component is the Ti blank, which is used to mill finished custom abutments in the laboratory. There are fewer laboratories milling custom abutments in-house, but those laboratories are most likely misinformed as to what the FDA requires for that automated manufacturing process. These laboratories do not need their own 510(k), according to the 2017 510(k) Indication for Use change for Ti blanks; they need only operate under a Quality System and maintain an Establishment Registration with the FDA as a contract manufacturer for the original equipment manufacturer (OEM).

Fortunately, there are many milling centers offering their services to dental laboratories that are operating under a Quality System and are FDA Establishment Registered. These FDA-compliant milling centers are subject to audits to validate their compliance with the FDA's Title 21 CFR 820.⁴ When the laboratory outsources the manufacture of abutments, it must make certain that all the abutments it receives are truly FDA compliant. The laboratory must protect its business by confirming that any outsourcing partner is completely FDA compliant.

What Makes Ti Bases and Blanks Different?

All dental implant abutments have the same FDA product code (NHA), so why do the Ti bases and blanks have different requirements?⁵ The FDA Dental Division's position is that all other implant abutments, such as multi-unit abutments (MUAs), are finished devices. They are removed from their packages and in many cases become part of the implant-supported restoration without modification. Other implant abutments require minimal adjustment by hand, and those all fall under the same code with no FDA oversight.

The difference is that the FDA does not consider these two components to be "abutments." According to the author's correspondence with the FDA, the Ti base does not become an abutment until the superstructure is created for it. Then, and only then, they are finished devices. The FDA has deemed that the final manufacturer of these components is in the dental laboratory or VMC. This is what separates the Ti bases and blanks from all other implant abutments. By these regulations, the dental laboratory is the final finished device manufacturer and as such must operate under a Quality System and Establishment Registration with the FDA as a contract manufacturer for the OEM.

Enforcement of FDA Requirements

The FDA's goal is to control the manufacture of these devices through Quality Systems and registered validated milling centers. It is the author's belief that the 510(k) Indications for Use statement is intended to encourage Ti base and blank manufacturing companies to require their laboratory customers to become VMCs.

To date, this approach has not worked. The companies that manufacture and distribute these components do not want to be FDA enforcers without clear and published written guidance detailing the requirement to the dental laboratories. Based on current sales practices, a laboratory will get the components they order, regardless of their status as a VMC. It is up to the laboratory to make sure they are using them properly.

Consider the consequences when bringing the milling of custom abutments or bars in-house. There are existing software systems that provide the capability to mill each of these from a Ti disc. This operation requires a 510(k) for the manufacturing of complete abutments and bars that include the implant/abutment connection. Doing this without a 510(k) is clearly illegal. The FDA has not been reticent about taking action against dental laboratories that are unknowingly manufacturing with discs that are not FDA compliant. It is always best to understand the FDA requirements and the laboratory's manufacturing limits. For those who are unsure, it is best to contact someone else who can provide clarity.

Preparing for Change

Based on the author's observation, the FDA has recognized that it has not achieved its goal of controlling Ti base and blank manufacturing. It is now requiring more stringent wording in the Indication for Use statements in the most recently submitted 510(k)s. The true impact of this will become apparent in the future. The FDA may provide clearer written guidance on this subject and give laboratories the time to prepare for more FDA oversight and enforcement.

In the end, suppliers are not responsible for the manufacturing processes within the laboratory. It is up to the laboratory to be FDA compliant and meet all the FDA requirements for Class II device final manufacturing in the laboratory. The laboratory will not be able to place the blame on the supplier for failing to provide information about the Ti base and blank requirements. Be informed and aware.

It is overwhelmingly likely that the FDA will use their team of newly acquired and recently trained dental inspectors to audit Ti base and blank manufacturing companies and determine how many dental laboratories are providing unfinished components for final device manufacturing. It is unclear when this will take place, but the time to prepare is now. For those who want to be proactive for the inevitable occurrence, the best course of action is to implement a Quality System in the laboratory now and prepare for the need to become a VMC. Connect with a knowledgeable dental regulatory firm to get the most up-to-date FDA requirements and make sure all laboratory operations are in compliance.

Start taking the necessary steps now, and it will not take long to be in full compliance. The implementation of a Quality System can take several training sessions and only needs to cover the procedures involved with Ti base and blank processing. The final step to maintain legal operations when the FDA enforces these requirements is to register with the FDA. It only takes about a week. Be ready with a Quality System installed, and don't let the FDA requirement disrupt your dental implant department's production. This is a "not if, but when" situation; a laboratory owner should be proactive and consider the "when" to be "now."

About the Authors

Tim Torbenson
President
EVO820

References

1. Torbenson T. Grow your laboratory with the understanding of the FDA requirements. EVO820. https://www.evo820.com/grow-your-laboratory-with-the-understanding-of-the-fda-requirements/. Published June 16, 2020. Accessed November 5, 2021. 

2. U.S. Food & Drug Administration. Quality system (QS) regulation/medical device good manufacturing practices. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices#applicability. Updated September 27, 2018. Accessed November 5, 2021. 

3. U.S. Food & Drug Administration. Who must register, list and pay the fee. https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee#definitions. Updated September 27, 2018. Accessed November 5, 2021. 

4. U.S. Food & Drug Administration. CFR - Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820. Updated April 1, 2021. Accessed November 5, 2021. 

5. U.S. Food & Drug Administration. Product classification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NHA. Updated November 1, 2021. Accessed November 5, 2021.