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FDA 510(k)

MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS

K-Number: K080598 · 2008-05-21

ApplicantIntra-Lock International
Decision Date2008-05-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Lock International. It received FDA 510(k) clearance on 2008-05-21 under 510(k) number K080598. 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 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS?

MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS is a medical device that received FDA 510(k) clearance on 2008-05-21. The listed applicant is Intra-Lock International. The 510(k) number is K080598.

When did MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS receive FDA 510(k) clearance?

MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS received FDA 510(k) clearance on 2008-05-21, under 510(k) number K080598.

Who is the listed applicant for MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS?

The FDA 510(k) record lists Intra-Lock International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS?

The FDA product code for MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS is NHA.

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Other records listing Intra-Lock International 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.

K130140INTRA-LOCK OP DENTAL IMPLANTK070601MINI DRIVE-LOCK DENTAL IMPLANT SYSTEMK050970MILO DENTAL IMPLANT SYSTEMK040205INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTSK031322INTRA-LOCK HYDROXYAPATITE COATED IMPLANTSK021915TRANSITIONAL IMPLANTS

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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.

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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