Cleared Traditional

K852489 - PROPOL DENTAL POLISHING PASTE

K852489 is the FDA 510(k) clearance for PROPOL DENTAL POLISHING PASTE by Scientific Pharmaceuticals, Inc.. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K852489 · Scientific Pharmaceuticals, Inc. · Dental device
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Jul 1985
Decision
24d
Days
Class 1
Risk

K852489 is an FDA 510(k) clearance for the PROPOL DENTAL POLISHING PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 24 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K852489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date July 01, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 26
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K852489.
DENSCO PROPHY PASTE
K854829 · Scientific Pharmaceuticals, Inc. · Mar 1986
GLOSSY POLISHING PASTE
K852814 · Scientific Pharmaceuticals, Inc. · Jul 1985
TEMREX DENTAL POLISHING PASTE
K852157 · Scientific Pharmaceuticals, Inc. · Jul 1985
KERR COMMAND ULTRAFINE POLISHING PASTE
K843022 · Kerr Corporation (Danbury) · Aug 1984
LUSTER, DENTAL POLISHING PASTE
K842403 · Scientific Pharmaceuticals, Inc. · Aug 1984
MIRADAPT* POLISHING INSTRUMENTS
K791319 · Johnson & Johnson Professionals, Inc. · Sep 1979