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FDA 510(k)

LW Implant System – Abutment

K-Number: K233167 · 2024-03-25

ApplicantOssvis Co., Ltd.
Decision Date2024-03-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LW Implant System – Abutment 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 2024-03-25 under 510(k) number K233167. 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 Implant System – Abutment?

LW Implant System – Abutment is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K233167.

When did LW Implant System – Abutment receive FDA 510(k) clearance?

LW Implant System – Abutment received FDA 510(k) clearance on 2024-03-25, under 510(k) number K233167.

Who is the listed applicant for LW Implant System – Abutment?

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 Implant System – Abutment?

The FDA product code for LW Implant System – Abutment is NHA.

Other records listing Ossvis 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.

K242703LW Pre-milled AbutmentK242379LL Implant SystemK233808LW Narrow Implant SystemK231235LW UCLA AbutmentK231079LW Retraction CapK223924LW Implant System

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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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