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FDA 510(k)

Allied Biocompat Abutment for Nobel Replace Interface

K-Number: K152845 · 2016-03-14

ApplicantAllied Dental Solutions
Decision Date2016-03-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Allied Biocompat Abutment for Nobel Replace Interface is the device name listed in this FDA 510(k) record. The listed applicant is Allied Dental Solutions. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K152845. 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 Allied Biocompat Abutment for Nobel Replace Interface?

Allied Biocompat Abutment for Nobel Replace Interface is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Allied Dental Solutions. The 510(k) number is K152845.

When did Allied Biocompat Abutment for Nobel Replace Interface receive FDA 510(k) clearance?

Allied Biocompat Abutment for Nobel Replace Interface received FDA 510(k) clearance on 2016-03-14, under 510(k) number K152845.

Who is the listed applicant for Allied Biocompat Abutment for Nobel Replace Interface?

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

What is the FDA product code for Allied Biocompat Abutment for Nobel Replace Interface?

The FDA product code for Allied Biocompat Abutment for Nobel Replace Interface is NHA.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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