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510(k) K012160

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 by Premier Dental Products Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2001
Date Received
July 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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