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FDA 510(k)

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS

K-Number: K072642 · 2007-12-20

ApplicantBiomet 3i, Inc.
Decision Date2007-12-20
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS 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 2007-12-20 under 510(k) number K072642. 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 BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS?

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Biomet 3i, Inc.. The 510(k) number is K072642.

When did BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS receive FDA 510(k) clearance?

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS received FDA 510(k) clearance on 2007-12-20, under 510(k) number K072642.

Who is the listed applicant for BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS?

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 BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS?

The FDA product code for BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS 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 IMPLANTSK110565ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACEK100724OSSEOTITE II MODEL XIFOSSXXXK101608BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTSK101607BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTSK102209ENCODE PATIENT SPECIFIC ABUTMENT

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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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