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FDA 510(k)

AccelX Abutments

K-Number: K203240 · 2021-04-27

ApplicantIntegrated Dental Systems, LLC
Decision Date2021-04-27
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AccelX Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Dental Systems, LLC. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K203240. 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 AccelX Abutments?

AccelX Abutments is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Integrated Dental Systems, LLC. The 510(k) number is K203240.

When did AccelX Abutments receive FDA 510(k) clearance?

AccelX Abutments received FDA 510(k) clearance on 2021-04-27, under 510(k) number K203240.

Who is the listed applicant for AccelX Abutments?

The FDA 510(k) record lists Integrated Dental Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccelX Abutments?

The FDA product code for AccelX Abutments 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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