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FDA 510(k)

NP-CAST ABUTMENT SYSTEM

K-Number: K121843 · 2012-12-11

ApplicantOsstem Implant Co., Ltd.
Decision Date2012-12-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NP-CAST ABUTMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K121843. 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 NP-CAST ABUTMENT SYSTEM?

NP-CAST ABUTMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K121843.

When did NP-CAST ABUTMENT SYSTEM receive FDA 510(k) clearance?

NP-CAST ABUTMENT SYSTEM received FDA 510(k) clearance on 2012-12-11, under 510(k) number K121843.

Who is the listed applicant for NP-CAST ABUTMENT SYSTEM?

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

What is the FDA product code for NP-CAST ABUTMENT SYSTEM?

The FDA product code for NP-CAST ABUTMENT SYSTEM is NHA.

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Other records listing Osstem Implant Co., Ltd. as applicant

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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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