Custom Abutments AS
K-Number: K253341 · 2025-12-23
ApplicantMedentika GmbH
Decision Date2025-12-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Custom Abutments AS is a medical device manufactured by Medentika GmbH. It received FDA 510(k) clearance on 2025-12-23 under approval number K253341. 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 Custom Abutments AS?
Custom Abutments AS is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Medentika GmbH. The 510(k) number is K253341.
When was Custom Abutments AS approved by the FDA?
Custom Abutments AS received FDA 510(k) clearance on 2025-12-23, under approval number K253341.
What company makes Custom Abutments AS?
Custom Abutments AS is manufactured by Medentika GmbH.
What is the FDA product code for Custom Abutments AS?
The FDA product code for Custom Abutments AS is NHA.
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K191123Multi-unit Abutments
K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
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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.