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510(k) K201940

Braces on Demand Bracket by Braces on Demand, Inc. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2020
Date Received
July 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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