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510(k) K214086

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty by Genoss Co., Ltd. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2022
Date Received
December 27, 2021
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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