Cleared Traditional

K820389 - A DENTAL AMALGAM ALLOY (UNNAMED

K820389 is the FDA 510(k) clearance for A DENTAL AMALGAM ALLOY (UNNAMED by Dentsply Intl.. It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K820389 · Dentsply Intl. · Dental device
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Mar 1982
Decision
29d
Days
Class 2
Risk

K820389 is an FDA 510(k) clearance for the A DENTAL AMALGAM ALLOY (UNNAMED. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Dentsply Intl. (Walker, US). The FDA issued a Cleared decision on March 11, 1982 after a review of 29 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 Dentsply Intl. devices

Submission Details

510(k) Number K820389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1982
Decision Date March 11, 1982
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K820389.
OLYMPIA ALLOY
K881333 · J.F. Jelenko & Co., Inc. · Apr 1988
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K875344 · Kulzer, Inc. · Mar 1988
VALULINE* AMALGAM ALLOY
K821971 · Johnson & Johnson Professionals, Inc. · Jul 1982
SYBRON/KERR CONTOUR
K820181 · Sybron Corp. · Feb 1982
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
K771383 · Johnson & Johnson Professionals, Inc. · Aug 1977