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510(k) K130647

XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML by Heraeus Kulzer, LLC — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2013
Date Received
March 11, 2013
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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