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510(k) K233954

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu by B&E Korea Co., Ltd. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2024
Date Received
December 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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