510(k) K070538

XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE by Dentsply Intl. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2007
Date Received
February 26, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type