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FDA 510(k)

ONE SYSTEM TAPERED TITANIUM ABUTMENTS

K-Number: K925349 · 1993-07-27

ApplicantImplant Support Systems, Inc.
Decision Date1993-07-27
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ONE SYSTEM TAPERED TITANIUM ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Implant Support Systems, Inc.. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K925349. 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 ONE SYSTEM TAPERED TITANIUM ABUTMENTS?

ONE SYSTEM TAPERED TITANIUM ABUTMENTS is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Implant Support Systems, Inc.. The 510(k) number is K925349.

When did ONE SYSTEM TAPERED TITANIUM ABUTMENTS receive FDA 510(k) clearance?

ONE SYSTEM TAPERED TITANIUM ABUTMENTS received FDA 510(k) clearance on 1993-07-27, under 510(k) number K925349.

Who is the listed applicant for ONE SYSTEM TAPERED TITANIUM ABUTMENTS?

The FDA 510(k) record lists Implant Support Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE SYSTEM TAPERED TITANIUM ABUTMENTS?

The FDA product code for ONE SYSTEM TAPERED TITANIUM ABUTMENTS is NHA.

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Other records listing Implant Support Systems, Inc. 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.

K933532SELF TAPPING DENTAL IMPLANT SYSTEMK924589RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMK925312HAND INSTRUMENT CALCULUS REMOVALK925313TITANIUM COC ABUTMENT HEADS FOR IMZK924190ISS O-RING ATTACHMENTK921764DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS

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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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