Disposable High Speed Air Turbine Handpiece
K-Number: K193264 · 2020-08-11
Decision Date2020-08-11
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Disposable High Speed Air Turbine Handpiece is a medical device manufactured by Ningbo Hpdove Dental Instruments Co., Ltd.. It received FDA 510(k) clearance on 2020-08-11 under approval number K193264. 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 Disposable High Speed Air Turbine Handpiece?
Disposable High Speed Air Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2020-08-11. It is manufactured by Ningbo Hpdove Dental Instruments Co., Ltd.. The 510(k) number is K193264.
When was Disposable High Speed Air Turbine Handpiece approved by the FDA?
Disposable High Speed Air Turbine Handpiece received FDA 510(k) clearance on 2020-08-11, under approval number K193264.
What company makes Disposable High Speed Air Turbine Handpiece?
Disposable High Speed Air Turbine Handpiece is manufactured by Ningbo Hpdove Dental Instruments Co., Ltd..
What is the FDA product code for Disposable High Speed Air Turbine Handpiece?
The FDA product code for Disposable High Speed Air Turbine Handpiece is EFB.
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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.