Cleared Traditional

K100539 - PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE

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

K100539 · Preventive Technologies, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K100539

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
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

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 76
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K100539.
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K100539 · PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
Download PDF FDA Summary Preventive Technologi…