Cleared Traditional

K040661 - RADENT PROPHY PASTE

K040661 is an FDA 510(k) clearance for RADENT PROPHY PASTE, manufactured by Pascal Co., Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K040661 · Pascal Co., Inc. · Dental device
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Jun 2004
Decision
89d
Days
Class 1
Risk

K040661 is an FDA 510(k) clearance for the RADENT PROPHY PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Pascal Co., Inc. (Bellevue, US). The FDA issued a Cleared decision on June 9, 2004 after a review of 89 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 - K040661

510(k) Number K040661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2004
Decision Date June 09, 2004
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 128d · This submission: 89d
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 K040661.
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
K041371 · Novamin Technology, Inc. · Aug 2004
ZIRCON-F PROPHYLAXIS PASTE
K040988 · Pascal Co., Inc. · Jul 2004
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
K033785 · Discus Dental, Inc. · Jun 2004
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
K033449 · Professional Dental Technologies Therapeutics, Inc. · Jan 2004
BUTLER GUM PROPHY PASTE WITH NOVAMIN
K024343 · Usbiomaterials Corp. · Jul 2003
PROCLUDE
K002989 · Ortek Therapeutics, Inc. · Dec 2000
K040661 · RADENT PROPHY PASTE
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