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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 a medical device manufactured by Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-09-27 under approval 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. It is manufactured by Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K220831.

When was Dental Implantation Systems, Dental Electrical Motors approved by the FDA?

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

What company makes Dental Implantation Systems, Dental Electrical Motors?

Dental Implantation Systems, Dental Electrical Motors is manufactured by Foshan Coxo Medical Instrument Co., Ltd..

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.

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT06898138 Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations NOT_YET_RECRUITING NCT06013956 Personalized Real-Time DBS and PD Mechanisms RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Other Devices by Foshan Coxo Medical Instrument Co., Ltd.

K220826LED Curing Light K212178Root Apex Locator K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors K220829Endo Motor K222096Endo Ultrasonic Activator K243921LED Curing Lights (DB686 HALO)

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Related Devices (Code: EBW)

K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH K163402NLZ Motor SystemNakanishi, Inc. K163131A-dec NLZ Electric Motor SystemNakanishi, Inc. K163317ELECTROmaticKaltenbach & Voigt Gmgh K161213XSmart iQDentsply Sirona K173905Surgic Pro, Surgic Pro+Nakanishi, 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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