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510(k) K010544

VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE by Apex Dental Materials, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2001
Date Received
February 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

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