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510(k) K120619

ORTHODONTIC FLOWABLE BRACKET ADHESIVE by Novocol, Inc. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2012
Date Received
February 29, 2012
Clearance Type
Abbreviated
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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  • K040343 — TEMP F (August 3, 2004)

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