Cleared Abbreviated

K063444 - TOTAL ETCH BONDING AGENT
(FDA 510(k) Clearance)

K063444 · Dmg USA, Inc. · Dental
Mar 2007
Decision
125d
Days
Class 2
Risk

K063444 is an FDA 510(k) clearance for the TOTAL ETCH BONDING AGENT. This device is classified as a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE).

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on March 20, 2007, 125 days after receiving the submission on November 15, 2006.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K063444 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2006
Decision Date March 20, 2007
Days to Decision 125 days
Submission Type Abbreviated
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