Cleared Traditional

K100539 - PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE

K100539 is the FDA 510(k) clearance for PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE by Preventive Technologies, Inc.. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K100539 · Preventive Technologies, Inc. · Dental device
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Jun 2010
Decision
112d
Days
Class 1
Risk

K100539 is an FDA 510(k) clearance for the PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Preventive Technologies, Inc. (Indian Trial, US). The FDA issued a Cleared decision on June 17, 2010 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 Preventive Technologies, Inc. devices

Submission Details

510(k) Number K100539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2010
Decision Date June 17, 2010
Days to Decision 112 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
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 - EJR Agent, Polishing, Abrasive, Oral Cavity

All 22
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K100539.
REMIN PRO
K101104 · Voco GmbH · Oct 2010
GC MI PASTE PLUS
K070854 · GC America, Inc. · Apr 2007
MI PASTE
K042200 · GC America, Inc. · Oct 2004
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991