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FDA 510(k)

SFIT Abutment

K-Number: K242287 · 2025-09-16

ApplicantCowellmedi Co., Ltd.
Decision Date2025-09-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SFIT Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2025-09-16 under 510(k) number K242287. 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 SFIT Abutment?

SFIT Abutment is a medical device that received FDA 510(k) clearance on 2025-09-16. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K242287.

When did SFIT Abutment receive FDA 510(k) clearance?

SFIT Abutment received FDA 510(k) clearance on 2025-09-16, under 510(k) number K242287.

Who is the listed applicant for SFIT Abutment?

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

What is the FDA product code for SFIT Abutment?

The FDA product code for SFIT Abutment is NHA.

Other records listing Cowellmedi 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.

K241127INNO SLA Mini Plus® Implant SystemK231411INNO SLA Submerged Hybrid Ti-Base SystemK232546Meta G UCLA AbutmentK231395INNO SLA Submerged Narrow Implant SystemK211554InnoGenic Non-resorbable MembraneK201323INNO SLA Submerged 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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