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510(k) K093575

GLUMA DESENSITIZER POWER GEL by Heraeus Kulzer, LLC — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2010
Date Received
November 18, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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