Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu— 510(k) K233954

Substantially Equivalent

B&E Korea Co., Ltd.

FDA 510(k) clearance K233954 for Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu, Substantially Equivalent on 2024-02-13. Applicant: B&E Korea Co., Ltd..

Clearance details

Applicant: B&E Korea Co., Ltd.
Product code: Code ELW
Advisory panel: Dental
Date received: 2023-12-15
Decision date: 2024-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

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