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510(k) K080311

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM by Dentsply Interntional — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2008
Date Received
February 6, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

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