Bonafix Implant Abutments
K-Number: K251294 · 2025-10-15
ApplicantZentek Medical, LLC
Decision Date2025-10-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bonafix Implant Abutments is a medical device manufactured by Zentek Medical, LLC. It received FDA 510(k) clearance on 2025-10-15 under approval number K251294. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bonafix Implant Abutments?
Bonafix Implant Abutments is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Zentek Medical, LLC. The 510(k) number is K251294.
When was Bonafix Implant Abutments approved by the FDA?
Bonafix Implant Abutments received FDA 510(k) clearance on 2025-10-15, under approval number K251294.
What company makes Bonafix Implant Abutments?
Bonafix Implant Abutments is manufactured by Zentek Medical, LLC.
What is the FDA product code for Bonafix Implant Abutments?
The FDA product code for Bonafix Implant Abutments is NHA.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.