FDA 510(k)

PROPHYflex 4

K-Number: K181110 · 2019-04-10

Decision Date2019-04-10

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PROPHYflex 4 is a medical device manufactured by Kaltenbach & Voigt GmbH. It received FDA 510(k) clearance on 2019-04-10 under approval number K181110. 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 PROPHYflex 4?

PROPHYflex 4 is a medical device that received FDA 510(k) clearance on 2019-04-10. It is manufactured by Kaltenbach & Voigt GmbH. The 510(k) number is K181110.

When was PROPHYflex 4 approved by the FDA?

PROPHYflex 4 received FDA 510(k) clearance on 2019-04-10, under approval number K181110.

What company makes PROPHYflex 4?

PROPHYflex 4 is manufactured by Kaltenbach & Voigt GmbH.

What is the FDA product code for PROPHYflex 4?

The FDA product code for PROPHYflex 4 is EFB.

Other Devices by Kaltenbach & Voigt GmbH

K161488ESTETICA Dental Treatment Unit and Accessories K163239SMARTmatic K182712DEXIS CariVu 3-in-1 by KaVo

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.