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FDA 510(k)

SD Abutment

K-Number: K173570 · 2019-05-17

ApplicantSurgident Co., Ltd.
Decision Date2019-05-17
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SD Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Surgident Co., Ltd.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K173570. 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 SD Abutment?

SD Abutment is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Surgident Co., Ltd.. The 510(k) number is K173570.

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

SD Abutment received FDA 510(k) clearance on 2019-05-17, under 510(k) number K173570.

Who is the listed applicant for SD Abutment?

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

What is the FDA product code for SD Abutment?

The FDA product code for SD Abutment is NHA.

Other records listing Surgident 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.

K170697GBR 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.

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

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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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