Cleared Traditional

K033449 - PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES

K033449 is an FDA 510(k) clearance for PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE..., manufactured by Professional Dental Technologies Therapeutics, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K033449 · Professional Dental Technologies Therapeutics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
70d
Days
Class 1
Risk

K033449 is an FDA 510(k) clearance for the PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Professional Dental Technologies Therapeutics, Inc. (Batesville, US). The FDA issued a Cleared decision on January 7, 2004 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033449

510(k) Number K033449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2003
Decision Date January 07, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
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 72
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K033449.
ZIRCON-F PROPHYLAXIS PASTE
K040988 · Pascal Co., Inc. · Jul 2004
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
K033785 · Discus Dental, Inc. · Jun 2004
RADENT PROPHY PASTE
K040661 · Pascal Co., Inc. · Jun 2004
BUTLER GUM PROPHY PASTE WITH NOVAMIN
K024343 · Usbiomaterials Corp. · Jul 2003
PROCLUDE
K002989 · Ortek Therapeutics, Inc. · Dec 2000
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
K033449 · PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
Download PDF FDA Summary Professional Dental T…