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FDA 510(k)

PRIMACONNEX CAD/CAM ABUTMENT SYSTEM

K-Number: K072241 · 2007-11-09

ApplicantLifecore Biomedical, Inc.
Decision Date2007-11-09
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIMACONNEX CAD/CAM ABUTMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 2007-11-09 under 510(k) number K072241. 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 PRIMACONNEX CAD/CAM ABUTMENT SYSTEM?

PRIMACONNEX CAD/CAM ABUTMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K072241.

When did PRIMACONNEX CAD/CAM ABUTMENT SYSTEM receive FDA 510(k) clearance?

PRIMACONNEX CAD/CAM ABUTMENT SYSTEM received FDA 510(k) clearance on 2007-11-09, under 510(k) number K072241.

Who is the listed applicant for PRIMACONNEX CAD/CAM ABUTMENT SYSTEM?

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

What is the FDA product code for PRIMACONNEX CAD/CAM ABUTMENT SYSTEM?

The FDA product code for PRIMACONNEX CAD/CAM ABUTMENT SYSTEM is NHA.

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Other records listing Lifecore Biomedical, 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.

K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSK072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSK072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSK062876PRIMACONNEX CERAMIC ABUTMENTSK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.K053643STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026

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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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