Cleared Traditional

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

K214086 · Genoss Co., Ltd. · Dental
Dec 2022
Decision
353d
Days
Class 2
Risk

About This 510(k) Submission

K214086 is an FDA 510(k) clearance for the Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on December 15, 2022, 353 days after receiving the submission on December 27, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K214086 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2021
Decision Date December 15, 2022
Days to Decision 353 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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