Cleared Traditional

K821226 - DENTAL AMALGAM ALLOY

K821226 is an FDA 510(k) clearance for DENTAL AMALGAM ALLOY, manufactured by Dental Alloyers Intl., Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K821226 · Dental Alloyers Intl., Inc. · Dental device
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Jun 1982
Decision
41d
Days
Class 2
Risk

K821226 is an FDA 510(k) clearance for the DENTAL AMALGAM ALLOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Dental Alloyers Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1982 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Dental Alloyers Intl., Inc. devices

FDA 510(k) Submission Details - K821226

510(k) Number K821226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date June 07, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 128d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJJ Alloy, Amalgam

All 46
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K821226.
LIMI ALLOY
K844653 · G-C Intl. Corp. · Mar 1985
SPHEREX E.C.T.
K822951 · Jeneric Ind. · Oct 1982
VALULINE* AMALGAM ALLOY
K821971 · Johnson & Johnson Professionals, Inc. · Jul 1982
A DENTAL AMALGAM ALLOY (UNNAMED
K820389 · Dentsply Intl. · Mar 1982
SYBRON/KERR CONTOUR
K820181 · Sybron Corp. · Feb 1982
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981