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510(k) K033309

PREMIER IMPLANT CEMENT, MODEL 3001450 by Premier Dental Products Co. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2004
Date Received
October 14, 2003
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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