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FDA 510(k)

LW Pre-milled Abutment

K-Number: K242703 · 2024-12-05

ApplicantOssvis Co., Ltd.
Decision Date2024-12-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LW Pre-milled 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 2024-12-05 under 510(k) number K242703. 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 Pre-milled Abutment?

LW Pre-milled Abutment is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Ossvis Co., Ltd.. The 510(k) number is K242703.

When did LW Pre-milled Abutment receive FDA 510(k) clearance?

LW Pre-milled Abutment received FDA 510(k) clearance on 2024-12-05, under 510(k) number K242703.

Who is the listed applicant for LW Pre-milled 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 Pre-milled Abutment?

The FDA product code for LW Pre-milled 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.

K242379LL Implant SystemK233808LW Narrow Implant SystemK233167LW Implant System – AbutmentK231235LW 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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