Cleared Traditional

MEDTROL DENTAL KIT (K953707) - FDA 510(k) Clearance

Class I Dental device.

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

K953707 is an FDA 510(k) clearance for the MEDTROL DENTAL KIT. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Medtrol, Inc. (Inverness, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtrol, Inc. devices

Submission Details

510(k) Number K953707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKJ Burnisher, Operative

Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K953707.
SUREFLEX FILES
K951607 · Dentsply Intl. · Jun 1995
PRESTERILIZED ENDODONTIC FILES
K943584 · Dentsply Intl. · Sep 1994
VITRABOND LIGHT CURE GLASS IONOMER LINER
K882821 · 3M Company · Sep 1988
DENTALVISION TV SYSTEM
K880542 · Dentsply Intl. · May 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · Baxter Healthcare Corp · Mar 1988