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510(k) K060698

CEMENT-IT ALL PURPOSE, MODEL N97 by Pentron Clinical Technologies — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
March 16, 2006
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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