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510(k) K082560

PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT by Kettenbach GmbH & Co. KG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2008
Date Received
September 4, 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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