Cleared Traditional

K840254 - DIAMOND LUSTRE

K840254 is an FDA 510(k) clearance for DIAMOND LUSTRE, manufactured by Jelrus Technical Products Corp.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K840254 · Jelrus Technical Products Corp. · Dental device
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Apr 1984
Decision
93d
Days
Class 1
Risk

K840254 is an FDA 510(k) clearance for the DIAMOND LUSTRE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Jelrus Technical Products Corp. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 93 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.

View all Jelrus Technical Products Corp. devices

FDA 510(k) Submission Details - K840254

510(k) Number K840254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date April 25, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 128d · This submission: 93d
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 42
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K840254.
PROPOL DENTAL POLISHING PASTE
K852489 · 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
DEN-MAT POLISHING PASTE
K801225 · Den-Mat Corp. · Jun 1980
MIRADAPT* POLISHING INSTRUMENTS
K791319 · Johnson & Johnson Professionals, Inc. · Sep 1979
NIMETIC POLISHING PASTE
K771852 · Espe GmbH (Us) · Nov 1977