Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite— 510(k) K181604

Name: FDA 510(k) clearance K181604
Creator: U.S. Food and Drug Administration
Published: 2018-11-28

Substantially Equivalent

Hrs Co., Ltd.

FDA 510(k) clearance K181604 for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite, Substantially Equivalent on 2018-11-28. Applicant: Hrs Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hrs Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2018-06-19
Decision date: 2018-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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