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

by B&E KOREA Co., Ltd. 510(k)

Active United States

510(k) K233954

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233954 Date13 Feb 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ELW
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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