Cleared Traditional

XENO ADHESIVE WITH ACTIVATOR

K051463 · Dentsply Intl. · Dental
Jul 2005
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K051463 is an FDA 510(k) clearance for the XENO ADHESIVE WITH ACTIVATOR, 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 July 12, 2005, 39 days after receiving the submission on June 3, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K051463 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2005
Decision Date July 12, 2005
Days to Decision 39 days
Submission Type Traditional
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