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FDA 510(k)

ET US SS Prosthetic system

K-Number: K160670 · 2017-04-25

ApplicantOsstem Implant Co., Ltd.
Decision Date2017-04-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ET US SS Prosthetic 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 2017-04-25 under 510(k) number K160670. 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 ET US SS Prosthetic system?

ET US SS Prosthetic system is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K160670.

When did ET US SS Prosthetic system receive FDA 510(k) clearance?

ET US SS Prosthetic system received FDA 510(k) clearance on 2017-04-25, under 510(k) number K160670.

Who is the listed applicant for ET US SS Prosthetic 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 ET US SS Prosthetic system?

The FDA product code for ET US SS Prosthetic system is NHA.

Other records listing Osstem Implant 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.

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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.

K253999Universal 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.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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