Traus SIP10

FDA 510(k) K123695 · Saeshin Precision Co., Ltd.

Substantially Equivalent

510(k) numberK123695

Submission

Device name
Traus SIP10
Applicant
Saeshin Precision Co., Ltd.
Daegu, KR
Received
December 3, 2012
Decision date
December 18, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
EKY – Handpiece, Water-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Traus SIP10 cleared by the FDA?

Traus SIP10 (K123695) received a 510(k) decision of Substantially Equivalent on December 18, 2012, 15 days after the submission was received.

What is the product code of K123695?

The FDA product code is EKY – Handpiece, Water-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.