High speed air turbine handpiece
K-Number: K251389 · 2026-01-12
ApplicantFoshan Topmed Dental Co., Ltd.
Decision Date2026-01-12
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
High speed air turbine handpiece is a medical device manufactured by Foshan Topmed Dental Co., Ltd.. It received FDA 510(k) clearance on 2026-01-12 under approval number K251389. 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 air turbine handpiece?
High speed air turbine handpiece is a medical device that received FDA 510(k) clearance on 2026-01-12. It is manufactured by Foshan Topmed Dental Co., Ltd.. The 510(k) number is K251389.
When was High speed air turbine handpiece approved by the FDA?
High speed air turbine handpiece received FDA 510(k) clearance on 2026-01-12, under approval number K251389.
What company makes High speed air turbine handpiece?
High speed air turbine handpiece is manufactured by Foshan Topmed Dental Co., Ltd..
What is the FDA product code for High speed air turbine handpiece?
The FDA product code for High speed air turbine handpiece is EFB.
Other Devices by Foshan Topmed Dental 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.