TRAUS Air Dental Handpiece
K-Number: K221741 · 2023-02-22
ApplicantSaeshin Precision Co., Ltd.
Decision Date2023-02-22
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TRAUS Air Dental Handpiece is a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2023-02-22 under approval number K221741. 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 TRAUS Air Dental Handpiece?
TRAUS Air Dental Handpiece is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K221741.
When was TRAUS Air Dental Handpiece approved by the FDA?
TRAUS Air Dental Handpiece received FDA 510(k) clearance on 2023-02-22, under approval number K221741.
What company makes TRAUS Air Dental Handpiece?
TRAUS Air Dental Handpiece is manufactured by Saeshin Precision Co., Ltd..
What is the FDA product code for TRAUS Air Dental Handpiece?
The FDA product code for TRAUS Air Dental 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.