Cleared Special

XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE

K070538 · Dentsply Intl. · Dental
Mar 2007
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K070538 is an FDA 510(k) clearance for the XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 14, 2007, 16 days after receiving the submission on February 26, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K070538 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2007
Decision Date March 14, 2007
Days to Decision 16 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200