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FDA 510(k)

Dental High-speed Handpiece and Accessories

K-Number: K173943 · 2018-07-24

Decision Date2018-07-24
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental High-speed Handpiece and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Microp Technology (Taiwan), Inc.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K173943. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental High-speed Handpiece and Accessories?

Dental High-speed Handpiece and Accessories is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Microp Technology (Taiwan), Inc.. The 510(k) number is K173943.

When did Dental High-speed Handpiece and Accessories receive FDA 510(k) clearance?

Dental High-speed Handpiece and Accessories received FDA 510(k) clearance on 2018-07-24, under 510(k) number K173943.

Who is the listed applicant for Dental High-speed Handpiece and Accessories?

The FDA 510(k) record lists Microp Technology (Taiwan), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental High-speed Handpiece and Accessories?

The FDA product code for Dental High-speed Handpiece and Accessories is EFB.

Other records listing Microp Technology (Taiwan), Inc. 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.

Related Devices (Code: EFB)

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.

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.