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FDA 510(k)

TDS ABUTMENT FOR FRIADENT XIVE

K-Number: K103339 · 2011-03-31

ApplicantPou YU Biotechnology Co., Ltd.
Decision Date2011-03-31
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TDS ABUTMENT FOR FRIADENT XIVE is the device name listed in this FDA 510(k) record. The listed applicant is Pou YU Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K103339. 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 TDS ABUTMENT FOR FRIADENT XIVE?

TDS ABUTMENT FOR FRIADENT XIVE is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Pou YU Biotechnology Co., Ltd.. The 510(k) number is K103339.

When did TDS ABUTMENT FOR FRIADENT XIVE receive FDA 510(k) clearance?

TDS ABUTMENT FOR FRIADENT XIVE received FDA 510(k) clearance on 2011-03-31, under 510(k) number K103339.

Who is the listed applicant for TDS ABUTMENT FOR FRIADENT XIVE?

The FDA 510(k) record lists Pou YU Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDS ABUTMENT FOR FRIADENT XIVE?

The FDA product code for TDS ABUTMENT FOR FRIADENT XIVE is NHA.

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Other records listing Pou YU Biotechnology Co., Ltd. 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.

K100356TDS PRECISION DENTAL BARK091392TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARKK091693TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARKK091026TDS ABUTMENT FOR NOBEL BIOCARE REPLACEK081460TDS ABUTMENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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