TRAUS ENDO— 510(k) K212043

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K212043 for TRAUS ENDO, Substantially Equivalent on 2022-06-24. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2021-06-30
Decision date: 2022-06-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.