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510(k) K251196

Composite Orthodontic Brackets and Buttons by Ec Certification Service GmbH — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2025
Date Received
April 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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