Non-FDA Compliant Ti CAD/CAM Custom Abutments
What dentists should know for the sake of their patients and practices
Illegal titanium (Ti) CAD/CAM custom abutments are becoming more prevalent. According to a recent survey, 49% of all implant abutments are milled custom abutments.1 An increasing number of laboratories or milling centers are manufacturing illegal CAD/CAM custom abutments. The Food and Drug Administration (FDA) strictly regulates CAD/CAM customized abutments as well as implants.
However, many dental practices are unaware that these regulations are in place and often do not check the legality of their product. Do you know if your titanium CAD/CAM customized abutments are FDA 501(k) cleared? Are your patients’ CAD/CAM custom abutments manufactured by a registered inspected facility? There are only a handful of abutments in the United States that have proper clearance, including Atlantis®* from DENTSPLY, Inclusive®* from Glidewell, and Solidex®* from Creodent.
As Class II medical devices, titanium customized or patient-specific abutments are required to have 510(k) premarket clearance by the FDA. There is no general clearance for dental implant abutment milling blanks. Any company that manufactures CAD/CAM custom abutments should be registered and listed with the FDA.
*Registered trademarks of their respective owners.
The benefits of using a 510(k)-approved device and laboratory go beyond adherence to legal requirements; they attest to standards met by devices and the laboratories that produce them:
· 510(k)-approved devices undergo rigorous 5 million cycle bench testing.
· 510(k)-approved devices must be backed by detailed engineering drawings and reverse engineering drawings with statistical data to validate designs and fit tolerances.
· All 510(k)-approved devices are manufactured by FDA-registered facilities that are required to follow good manufacturing practices (GMP); they are audited by the FDA for the proper implementation of a quality management system similar to ISO 9000.
Providing quality restorations is not only for peace of mind. It is the fiduciary duty of dentists to verify that all products used by their practices are in compliance with the FDA. The legal liability that can result from a case failure due to poor quality is significant. Imagine if your patients knew their abutments and implants were not approved by the FDA.
Verifying FDA-Cleared Customized Abutments
All laboratory manufactured CAD/CAM customized abutments must have their own FDA 510(k) number. All registered labs have a FDA facility registration number. 510(k) and registration numbers can be verified on the FDA.gov website. When verifying online, abutments should be listed under the facility registration.
1. Carr KF. Survey snapshot: the implant market. LMT.com website. https://lmtmag.com/articles/71808. Accessed May 6, 2015.
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