Highspeed Airturbine Handpiece
K-Number: K202371 · 2021-11-08
Decision Date2021-11-08
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Highspeed Airturbine Handpiece is a medical device manufactured by Beijing Dongbo Dental Handpiece Co., Ltd.. It received FDA 510(k) clearance on 2021-11-08 under approval number K202371. 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 Highspeed Airturbine Handpiece?
Highspeed Airturbine Handpiece is a medical device that received FDA 510(k) clearance on 2021-11-08. It is manufactured by Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K202371.
When was Highspeed Airturbine Handpiece approved by the FDA?
Highspeed Airturbine Handpiece received FDA 510(k) clearance on 2021-11-08, under approval number K202371.
What company makes Highspeed Airturbine Handpiece?
Highspeed Airturbine Handpiece is manufactured by Beijing Dongbo Dental Handpiece Co., Ltd..
What is the FDA product code for Highspeed Airturbine Handpiece?
The FDA product code for Highspeed Airturbine Handpiece is EFB.
Other Devices by Beijing Dongbo Dental Handpiece Co., Ltd.
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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.