510(k) K073518

FLASHLITE REBEL* by Discus Dental, Inc. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
December 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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