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510(k) K123761

VITA ENAMIC STAINS by Innovation Meditech GmbH — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
December 7, 2012
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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