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510(k) K071055

OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 by Ultradent Products, Inc. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2007
Date Received
April 16, 2007
Clearance Type
Special
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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