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FDA 510(k)

A.B. Dental Devices Dental Implants System

K-Number: K202144 · 2022-09-23

ApplicantA.B. Dental Device , Ltd.
Decision Date2022-09-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A.B. Dental Devices Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is A.B. Dental Device , Ltd.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K202144. 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 A.B. Dental Devices Dental Implants System?

A.B. Dental Devices Dental Implants System is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is A.B. Dental Device , Ltd.. The 510(k) number is K202144.

When did A.B. Dental Devices Dental Implants System receive FDA 510(k) clearance?

A.B. Dental Devices Dental Implants System received FDA 510(k) clearance on 2022-09-23, under 510(k) number K202144.

Who is the listed applicant for A.B. Dental Devices Dental Implants System?

The FDA 510(k) record lists A.B. Dental Device , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.B. Dental Devices Dental Implants System?

The FDA product code for A.B. Dental Devices Dental Implants System is NHA.

Other records listing A.B. Dental Device , Ltd. 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.

K182455A.B. DENTAL DEVICES Dental Implants SystemK181381A.B. Dental Devices Dental Implants SystemK162482A.B. DENTAL DEVICES Dental Implants System

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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