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FDA 510(k)

Fiber Optic Brushless Electronic Micromotor, model: iM100

K-Number: K231864 · 2024-03-11

ApplicantCodent Technical Industry Co., Ltd.
Decision Date2024-03-11
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fiber Optic Brushless Electronic Micromotor, model: iM100 is the device name listed in this FDA 510(k) record. The listed applicant is Codent Technical Industry Co., Ltd.. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K231864. 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 Fiber Optic Brushless Electronic Micromotor, model: iM100?

Fiber Optic Brushless Electronic Micromotor, model: iM100 is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Codent Technical Industry Co., Ltd.. The 510(k) number is K231864.

When did Fiber Optic Brushless Electronic Micromotor, model: iM100 receive FDA 510(k) clearance?

Fiber Optic Brushless Electronic Micromotor, model: iM100 received FDA 510(k) clearance on 2024-03-11, under 510(k) number K231864.

Who is the listed applicant for Fiber Optic Brushless Electronic Micromotor, model: iM100?

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

What is the FDA product code for Fiber Optic Brushless Electronic Micromotor, model: iM100?

The FDA product code for Fiber Optic Brushless Electronic Micromotor, model: iM100 is EBW.

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

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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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