Cleared Traditional

K942851 - SMILE INTEGRATED PROPHYLAXIS PASTE RINGS

K942851 is an FDA 510(k) clearance for SMILE INTEGRATED PROPHYLAXIS PASTE RINGS, manufactured by Germiphene Corp.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K942851 · Germiphene Corp. · Dental device
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Nov 1994
Decision
141d
Days
Class 1
Risk

K942851 is an FDA 510(k) clearance for the SMILE INTEGRATED PROPHYLAXIS PASTE RINGS. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Germiphene Corp. (L5n 1n7, CA). The FDA issued a Cleared decision on November 4, 1994 after a review of 141 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K942851

510(k) Number K942851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1994
Decision Date November 04, 1994
Days to Decision 141 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
13d slower than avg
Panel avg: 128d · This submission: 141d
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 60
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K942851.
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999
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
PROPHY PASTE
K940496 · Challenge Products, Inc. · Apr 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
K942851 · SMILE INTEGRATED PROPHYLAXIS PASTE RINGS
Download PDF Germiphene Corp.