Cleared Traditional

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

K233954 · B&E Korea Co., Ltd. · Dental
Feb 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K233954 is an FDA 510(k) clearance for the Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu, a Material, Impression (Class II — Special Controls, product code ELW), submitted by B&E Korea Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 13, 2024, 60 days after receiving the submission on December 15, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K233954 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2023
Decision Date February 13, 2024
Days to Decision 60 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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