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510(k) K080882

CEREC OPTI SPRAY by Sirona Dental Systems GmbH — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2008
Date Received
March 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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