Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty— 510(k) K214086

Name: FDA 510(k) clearance K214086
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K214086 for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty, Substantially Equivalent on 2022-12-15. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2021-12-27
Decision date: 2022-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, 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.