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FDA 510(k)

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

K-Number: K240337 · 2024-11-13

ApplicantGuangdong Jinme Medical Technology Co., Ltd.
Decision Date2024-11-13
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is a medical device manufactured by Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-13 under approval number K240337. 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 Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is a medical device that received FDA 510(k) clearance on 2024-11-13. It is manufactured by Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K240337.

When was Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) approved by the FDA?

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) received FDA 510(k) clearance on 2024-11-13, under approval number K240337.

What company makes Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is manufactured by Guangdong Jinme Medical Technology Co., Ltd..

What is the FDA product code for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)?

The FDA product code for Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) is EFB.

Related Clinical Trials

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT05585905 Virtual Reality in Pediatric Dentistry COMPLETED NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED

Other Devices by Guangdong Jinme Medical Technology Co., Ltd.

K170236Dental Low-speed Turbine Handpiece K170229Dental High-speed Turbine Handpiece K240340Surgical Drive System (Model: ES70, ES90, E8)

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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