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FDA 510(k)

BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE

K-Number: K103291 · 2011-11-04

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2011-11-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K103291. 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 BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE?

BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K103291.

When did BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE receive FDA 510(k) clearance?

BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE received FDA 510(k) clearance on 2011-11-04, under 510(k) number K103291.

Who is the listed applicant for BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE?

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

What is the FDA product code for BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE?

The FDA product code for BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE is NHA.

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Other records listing BioHorizons Implant 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.

K260061BioHorizons CEREC Compatible Ti-BasesK243521Conical Ti Base abutmentsK240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentK240187Tapered Pro Conical Implant SystemK223697MRI compatibility for existing BioHorizons dental implants and abutmentsK203252Multi-unit Abutments for CONELOG

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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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