Cleared Traditional

CONFI-BOND

K955328 · Confi-Dental Products Co. · Dental
Mar 1996
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K955328 is an FDA 510(k) clearance for the CONFI-BOND, 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 March 28, 1996, 129 days after receiving the submission on November 20, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K955328 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date March 28, 1996
Days to Decision 129 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