510(k) K093019

ENAMELITE ACRYSEAL SPRAY SEALANT by Enamelite, LLC — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2009
Date Received
September 29, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type