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510(k) K200153

Bright Bond Universal by Genoss Co., Ltd. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2020
Date Received
January 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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