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FDA 510(k)

Cemented Plus Abutment

K-Number: K262207 · 2026-09-23

ApplicantUnidental Co., Ltd.
Decision Date2026-09-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cemented Plus Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Unidental Co., Ltd.. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K262207. 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 Cemented Plus Abutment?

Cemented Plus Abutment is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Unidental Co., Ltd.. The 510(k) number is K262207.

When did Cemented Plus Abutment receive FDA 510(k) clearance?

Cemented Plus Abutment received FDA 510(k) clearance on 2026-09-23, under 510(k) number K262207.

Who is the listed applicant for Cemented Plus Abutment?

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

What is the FDA product code for Cemented Plus Abutment?

The FDA product code for Cemented Plus Abutment is NHA.

Other records listing Unidental 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.

K221315UNIdental Symphony Implant System

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.

K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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