Cleared Traditional

K944575 - AQUAFRESH PLAQUE FIGHTING GUM

K944575 is an FDA 510(k) clearance for AQUAFRESH PLAQUE FIGHTING GUM, manufactured by Smithkline Beecham Consumer Healthcare Products. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K944575 · Smithkline Beecham Consumer Healthcare Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
87d
Days
Class 1
Risk

K944575 is an FDA 510(k) clearance for the AQUAFRESH PLAQUE FIGHTING GUM. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Smithkline Beecham Consumer Healthcare Products (Parsippany, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 87 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.

View all Smithkline Beecham Consumer Healthcare Products devices

FDA 510(k) Submission Details - K944575

510(k) Number K944575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date December 15, 1994
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
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 30
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K944575.
MI PASTE
K042200 · GC America, Inc. · Oct 2004
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
PULPDENT DIAMOND POLISH
K911284 · Pulpdent Corp. · May 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990