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510(k) K933199

CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL by Confi-Dental Products Co. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1994
Date Received
April 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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