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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2025-12-23 under 510(k) 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. The listed applicant is Medentika GmbH. The 510(k) number is K253341.

When did Custom Abutments AS receive FDA 510(k) clearance?

Custom Abutments AS received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253341.

Who is the listed applicant for Custom Abutments AS?

The FDA 510(k) record lists Medentika GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custom Abutments AS?

The FDA product code for Custom Abutments AS is NHA.

Other records listing Medentika GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242542Medentika CAD/CAM AbutmentsK223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit AbutmentsK201711CARES Screw - Retained Bars and Bridges (SRBB)K200906MINICONE ImplantK191123Multi-unit AbutmentsK180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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.

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