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FDA 510(k)

AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM

K-Number: K080397 · 2008-05-06

ApplicantAmerican Dental Implant Corporation
Decision Date2008-05-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Implant Corporation. It received FDA 510(k) clearance on 2008-05-06 under 510(k) number K080397. 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 AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM?

AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-06. The listed applicant is American Dental Implant Corporation. The 510(k) number is K080397.

When did AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM receive FDA 510(k) clearance?

AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM received FDA 510(k) clearance on 2008-05-06, under 510(k) number K080397.

Who is the listed applicant for AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM?

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

What is the FDA product code for AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM?

The FDA product code for AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM is NHA.

Related Clinical Trials

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.

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Other records listing American Dental Implant Corporation 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.

K042462AMERICAN DENTAL IMPLANT

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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

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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