Cleared Traditional

ETCHANT 40%

K030743 · Confi-Dental Products Co. · Dental
May 2003
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K030743 is an FDA 510(k) clearance for the ETCHANT 40%, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Confi-Dental Products Co. (Louisville, US). The FDA issued a Cleared decision on May 9, 2003, 60 days after receiving the submission on March 10, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K030743 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2003
Decision Date May 09, 2003
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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