Cleared Traditional

LUSTER, DENTAL POLISHING PASTE (K842403) - FDA 510(k) Clearance

Class I Dental device.

K842403 · Scientific Pharmaceuticals, Inc. · Dental device
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Aug 1984
Decision
59d
Days
Class 1
Risk

K842403 is an FDA 510(k) clearance for the LUSTER, DENTAL POLISHING PASTE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Walker, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 59 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 K842403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date August 17, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
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 7
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K842403.
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226 · Johnson & Johnson Professionals, Inc. · May 1987
MIRADAPT* POLISHING INSTRUMENTS
K791319 · Johnson & Johnson Professionals, Inc. · Sep 1979