SILDENT— 510(k) K132869

Substantially Equivalent

Hrs Co., Ltd.

FDA 510(k) clearance K132869 for SILDENT, Substantially Equivalent on 2014-06-19. 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: 2013-09-13
Decision date: 2014-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyongtaek, 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.