Cleared Traditional

K822142 - DIAGLAZE

K822142 is an FDA 510(k) clearance for DIAGLAZE, manufactured by Antraco, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K822142 · Antraco, Inc. · Dental device
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Sep 1982
Decision
56d
Days
Class 1
Risk

K822142 is an FDA 510(k) clearance for the DIAGLAZE. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Antraco, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 56 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 Antraco, Inc. devices

FDA 510(k) Submission Details - K822142

510(k) Number K822142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1982
Decision Date September 14, 1982
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 128d · This submission: 56d
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 K822142.
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