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510(k) K180718

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES by Tomy, Inc. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2018
Date Received
March 19, 2018
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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