Cleared Traditional

MEDTROL DENTAL KIT

K953707 · Medtrol, Inc. · Dental
Jan 1996
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K953707 is an FDA 510(k) clearance for the MEDTROL DENTAL KIT, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Medtrol, Inc. (Inverness, US). The FDA issued a Cleared decision on January 4, 1996, 149 days after receiving the submission on August 8, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K953707 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1995
Decision Date January 04, 1996
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EKJ — Burnisher, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565