Cleared Special

ECLIPSE BONDING AGENT

K051707 · Dentsply Intl. · Dental
Jul 2005
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K051707 is an FDA 510(k) clearance for the ECLIPSE BONDING AGENT, 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 15, 2005, 18 days after receiving the submission on June 27, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K051707 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2005
Decision Date July 15, 2005
Days to Decision 18 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