510(k) K052593

FUSION CURING LIGHT by Dentlight, Inc. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2005
Date Received
September 21, 2005
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