Cleared Traditional

K820738 - LUSTRALLOY

K820738 is an FDA 510(k) clearance for LUSTRALLOY, manufactured by Hoyt Laboratories. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K820738 · Hoyt Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
22d
Days
Class 2
Risk

K820738 is an FDA 510(k) clearance for the LUSTRALLOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Hoyt Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 22 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 Hoyt Laboratories devices

FDA 510(k) Submission Details - K820738

510(k) Number K820738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1982
Decision Date April 09, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 128d · This submission: 22d
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 K820738.
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