High-speed Turbine Handpieces for Single Use
K-Number: K172543 · 2018-07-11
Decision Date2018-07-11
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
High-speed Turbine Handpieces for Single Use is a medical device manufactured by Beijing Dongbo Dental Handpiece Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under approval number K172543. 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 High-speed Turbine Handpieces for Single Use?
High-speed Turbine Handpieces for Single Use is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K172543.
When was High-speed Turbine Handpieces for Single Use approved by the FDA?
High-speed Turbine Handpieces for Single Use received FDA 510(k) clearance on 2018-07-11, under approval number K172543.
What company makes High-speed Turbine Handpieces for Single Use?
High-speed Turbine Handpieces for Single Use is manufactured by Beijing Dongbo Dental Handpiece Co., Ltd..
What is the FDA product code for High-speed Turbine Handpieces for Single Use?
The FDA product code for High-speed Turbine Handpieces for Single Use is EFB.
Related Clinical Trials
NCT02710916
SD-OCT Multimodal Analysis in GLaucoma
COMPLETED
NCT07034521
The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors
RECRUITING
NCT06941779
CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease
COMPLETED
NCT07336667
The Effect of Robot-Assisted Gait Training With or Without Plantar Pressure Summary Feedback: Impact on Gait Symmetry and Balance in Hemiplegic Patients
ACTIVE_NOT_RECRUITING
NCT07539272
Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
NOT_YET_RECRUITING
NCT02510521
Effects of Neuro-myo-electrical Stimulation on Insulin Sensitivity in Patients With Type 2 Diabetes
COMPLETED
Other Devices by Beijing Dongbo Dental Handpiece Co., Ltd.
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.