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FDA 510(k)

SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT

K-Number: K083876 · 2010-02-26

ApplicantCendres & Metaux SA
Decision Date2010-02-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Cendres & Metaux SA. It received FDA 510(k) clearance on 2010-02-26 under 510(k) number K083876. 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 SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT?

SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Cendres & Metaux SA. The 510(k) number is K083876.

When did SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT receive FDA 510(k) clearance?

SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT received FDA 510(k) clearance on 2010-02-26, under 510(k) number K083876.

Who is the listed applicant for SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT?

The FDA 510(k) record lists Cendres & Metaux SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT?

The FDA product code for SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT is NHA.

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Other records listing Cendres & Metaux SA 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.

K131526SFI-BARK123638PEKKTON IVORYK111390SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..K102382SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT

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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