Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dental High-speed Handpiece and Accessories

K-Number: K173943 · 2018-07-24

ApplicantMicrop Technology (Taiwan), Inc.
Decision Date2018-07-24
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental High-speed Handpiece and Accessories is a medical device manufactured by Microp Technology (Taiwan), Inc.. It received FDA 510(k) clearance on 2018-07-24 under approval 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. It is manufactured by Microp Technology (Taiwan), Inc.. The 510(k) number is K173943.

When was Dental High-speed Handpiece and Accessories approved by the FDA?

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

What company makes Dental High-speed Handpiece and Accessories?

Dental High-speed Handpiece and Accessories is manufactured by Microp Technology (Taiwan), Inc..

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 Devices by Microp Technology (Taiwan), Inc.

K202786Dental Low-speed Handpieces and Accessories

Related Devices (Code: EFB)

K160410WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small headDental Savings Club K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed HandpieceDentalez, Inc. K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A K171174PERIO-FLOW nozzleE.M.S Electro Medical Systems S.A K171553W&H Assistina TwinW&H Dentalwerk Buermoos GmbH K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.

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.

↑