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510(k) K131212

PREMIER CERAMIC PRIMER by Premier Dental Products Co. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2013
Date Received
April 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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