TRAUS Dental Handpieces
K-Number: K182892 · 2019-11-26
ApplicantSaeshin Precision Co., Ltd.
Decision Date2019-11-26
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TRAUS Dental Handpieces is a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-11-26 under approval number K182892. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRAUS Dental Handpieces?
TRAUS Dental Handpieces is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K182892.
When was TRAUS Dental Handpieces approved by the FDA?
TRAUS Dental Handpieces received FDA 510(k) clearance on 2019-11-26, under approval number K182892.
What company makes TRAUS Dental Handpieces?
TRAUS Dental Handpieces is manufactured by Saeshin Precision Co., Ltd..
What is the FDA product code for TRAUS Dental Handpieces?
The FDA product code for TRAUS Dental Handpieces is EGS.
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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.