510(k) K092141

VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH by 3M Espe Dental Products — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2010
Date Received
July 15, 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