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510(k) K061427

PRE-IMPRESSION CONDITIONING SOLUTION by Dentsply Intl. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2006
Date Received
May 23, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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