510(k) K072830

RM BOND, MODEL J032 by Pentron Clinical Technologies — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2007
Date Received
October 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type