Cleared Traditional

K940496 - PROPHY PASTE

K940496 is an FDA 510(k) clearance for PROPHY PASTE, manufactured by Challenge Products, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K940496 · Challenge Products, Inc. · Dental device
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Apr 1994
Decision
76d
Days
Class 1
Risk

K940496 is an FDA 510(k) clearance for the PROPHY PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Challenge Products, Inc. (Chicago, US). The FDA issued a Cleared decision on April 19, 1994 after a review of 76 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 - K940496

510(k) Number K940496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1994
Decision Date April 19, 1994
Days to Decision 76 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
52d faster than avg
Panel avg: 128d · This submission: 76d
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 K940496.
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
K962370 · Challenge Products, Inc. · Mar 1997
AQUAFRESH PLAQUE FIGHTING GUM
K944575 · Smithkline Beecham Consumer Healthcare Products · Dec 1994
SMILE INTEGRATED PROPHYLAXIS PASTE RINGS
K942851 · Germiphene Corp. · Nov 1994
VISION PROPHY PASTE WITH FLUORIDE
K935925 · Block Drug Company, Inc. · Jan 1994
VISION PROPHY PASTE WITHOUT FLUORIDE
K933893 · Block Drug Company, Inc. · Nov 1993
DENSPRO COARSE MINT PROPHY PASTE
K923674 · Teledyne Getz · Nov 1992
K940496 · PROPHY PASTE
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