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FDA 510(k)

LW Retraction Cap

K-Number: K231079 · 2023-09-14

ApplicantOssvis Co., Ltd.
Decision Date2023-09-14
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LW Retraction Cap is the device name listed in this FDA 510(k) record. The listed applicant is Ossvis Co., Ltd.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K231079. 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 LW Retraction Cap?

LW Retraction Cap is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K231079.

When did LW Retraction Cap receive FDA 510(k) clearance?

LW Retraction Cap received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231079.

Who is the listed applicant for LW Retraction Cap?

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

What is the FDA product code for LW Retraction Cap?

The FDA product code for LW Retraction Cap is NHA.

Other records listing Ossvis Co., Ltd. as applicant

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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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