Medidenta High Speed Handpieces
K-Number: K202674 · 2022-12-12
ApplicantPac-Dent, Inc.
Decision Date2022-12-12
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Medidenta High Speed Handpieces is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2022-12-12 under approval number K202674. 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 Medidenta High Speed Handpieces?
Medidenta High Speed Handpieces is a medical device that received FDA 510(k) clearance on 2022-12-12. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K202674.
When was Medidenta High Speed Handpieces approved by the FDA?
Medidenta High Speed Handpieces received FDA 510(k) clearance on 2022-12-12, under approval number K202674.
What company makes Medidenta High Speed Handpieces?
Medidenta High Speed Handpieces is manufactured by Pac-Dent, Inc..
What is the FDA product code for Medidenta High Speed Handpieces?
The FDA product code for Medidenta High Speed Handpieces is EFB.
Other Devices by Pac-Dent, Inc.
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.