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510(k) K083304

TEMPOSIL 2 by Coltene/Whaledent AG — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2009
Date Received
November 10, 2008
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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  • K112168 — COMPONEER (November 21, 2011)

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