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510(k) K011239

GINDA GUARD by Cosmedent, Inc. — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2002
Date Received
April 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

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