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FDA 510(k)

ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE

K-Number: K110565 · 2011-09-01

ApplicantBiomet 3i, Inc.
Decision Date2011-09-01
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, Inc.. It received FDA 510(k) clearance on 2011-09-01 under 510(k) number K110565. 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 ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE is a medical device that received FDA 510(k) clearance on 2011-09-01. The listed applicant is Biomet 3i, Inc.. The 510(k) number is K110565.

When did ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE receive FDA 510(k) clearance?

ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE received FDA 510(k) clearance on 2011-09-01, under 510(k) number K110565.

Who is the listed applicant for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

The FDA 510(k) record lists Biomet 3i, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE?

The FDA product code for ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE is NHA.

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Other records listing Biomet 3i, 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.

K111216OSSEOTITE 2 DENTAL IMPLANTSK100724OSSEOTITE II MODEL XIFOSSXXXK101608BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTSK101607BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTSK102209ENCODE PATIENT SPECIFIC ABUTMENTK101582CAM STRUCTSURE BARS

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Related Devices (Code: NHA)

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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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