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510(k) K140807

COMPOSITE ORTHODONTIC BRACKETS by Ortho Specialties — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2014
Date Received
April 1, 2014
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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