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FDA 510(k)

PROCERA BRIDGE LAMINATE, MODEL 40-4002

K-Number: K053068 · 2006-02-22

ApplicantNobel Biocare AB
Decision Date2006-02-22
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROCERA BRIDGE LAMINATE, MODEL 40-4002 is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2006-02-22 under 510(k) number K053068. 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 PROCERA BRIDGE LAMINATE, MODEL 40-4002?

PROCERA BRIDGE LAMINATE, MODEL 40-4002 is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Nobel Biocare AB. The 510(k) number is K053068.

When did PROCERA BRIDGE LAMINATE, MODEL 40-4002 receive FDA 510(k) clearance?

PROCERA BRIDGE LAMINATE, MODEL 40-4002 received FDA 510(k) clearance on 2006-02-22, under 510(k) number K053068.

Who is the listed applicant for PROCERA BRIDGE LAMINATE, MODEL 40-4002?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROCERA BRIDGE LAMINATE, MODEL 40-4002?

The FDA product code for PROCERA BRIDGE LAMINATE, MODEL 40-4002 is NHA.

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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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