510(k) K052349

AVANTE LED CURING UNIT, MODEL N44 by Pentron Clinical Technologies — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2005
Date Received
August 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type