Cleared Traditional

PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (K033785) - FDA 510(k) Clearance

Class I Dental device.

K033785 · Discus Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
197d
Days
Class 1
Risk

K033785 is an FDA 510(k) clearance for the PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Discus Dental, Inc. (Culver City, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 197 days - an extended review cycle.

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 Discus Dental, Inc. devices

Submission Details

510(k) Number K033785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date June 18, 2004
Days to Decision 197 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
70d slower than avg
Panel avg: 127d · This submission: 197d
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 76
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K033785.
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
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987