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FDA 510(k)

Concentrix MX-AC High-Speed Handpiece

K-Number: K173465 · 2018-03-28

ApplicantDentalez, Inc.
Decision Date2018-03-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Concentrix MX-AC High-Speed Handpiece is a medical device manufactured by Dentalez, Inc.. It received FDA 510(k) clearance on 2018-03-28 under approval number K173465. 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 Concentrix MX-AC High-Speed Handpiece?

Concentrix MX-AC High-Speed Handpiece is a medical device that received FDA 510(k) clearance on 2018-03-28. It is manufactured by Dentalez, Inc.. The 510(k) number is K173465.

When was Concentrix MX-AC High-Speed Handpiece approved by the FDA?

Concentrix MX-AC High-Speed Handpiece received FDA 510(k) clearance on 2018-03-28, under approval number K173465.

What company makes Concentrix MX-AC High-Speed Handpiece?

Concentrix MX-AC High-Speed Handpiece is manufactured by Dentalez, Inc..

What is the FDA product code for Concentrix MX-AC High-Speed Handpiece?

The FDA product code for Concentrix MX-AC High-Speed Handpiece is EFB.

Other Devices by Dentalez, Inc.

K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece K162397Titan 3 Low Speed Angle Attachments K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece

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.

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