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FDA 510(k)

Dental Implantation Systems, Dental Electrical Motors

K-Number: K220831 · 2022-09-27

ApplicantFoshan Coxo Medical Instrument Co., Ltd.
Decision Date2022-09-27
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implantation Systems, Dental Electrical Motors is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K220831. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Implantation Systems, Dental Electrical Motors?

Dental Implantation Systems, Dental Electrical Motors is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K220831.

When did Dental Implantation Systems, Dental Electrical Motors receive FDA 510(k) clearance?

Dental Implantation Systems, Dental Electrical Motors received FDA 510(k) clearance on 2022-09-27, under 510(k) number K220831.

Who is the listed applicant for Dental Implantation Systems, Dental Electrical Motors?

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

What is the FDA product code for Dental Implantation Systems, Dental Electrical Motors?

The FDA product code for Dental Implantation Systems, Dental Electrical Motors is EBW.

Other records listing Foshan Coxo Medical Instrument Co., Ltd. as applicant

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Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

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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