Dental Handpiece
K-Number: K192809 · 2020-08-25
ApplicantMicro-Nx Co., Ltd.
Decision Date2020-08-25
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dental Handpiece is a medical device manufactured by Micro-Nx Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under approval number K192809. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dental Handpiece?
Dental Handpiece is a medical device that received FDA 510(k) clearance on 2020-08-25. It is manufactured by Micro-Nx Co., Ltd.. The 510(k) number is K192809.
When was Dental Handpiece approved by the FDA?
Dental Handpiece received FDA 510(k) clearance on 2020-08-25, under approval number K192809.
What company makes Dental Handpiece?
Dental Handpiece is manufactured by Micro-Nx Co., Ltd..
What is the FDA product code for Dental Handpiece?
The FDA product code for Dental Handpiece is EFA.
Other Devices by Micro-Nx Co., Ltd.
Related Devices (Code: EFA)
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.