510(k) K880392

ORTHOLUX VISIBLE LIGHT CURING UNIT by Unitek Corp. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1988
Date Received
January 29, 1988
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