Cleared Traditional

DENTAL SOLDER ALLOY (K920060) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920060 · Deringer-Ney, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
87d
Days
Class 2
Risk

K920060 is an FDA 510(k) clearance for the DENTAL SOLDER ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on April 2, 1992 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Deringer-Ney, Inc. devices

Submission Details

510(k) Number K920060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date April 02, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K920060.
ARGELITE 85
K931554 · Argen Precious Metals, Inc. · Jul 1993
ARGELITE 55
K931475 · Argen Precious Metals, Inc. · Jul 1993
ARGENCO 75M
K924241 · Argen Precious Metals, Inc. · Nov 1992
ULTRACROWN(TM) PRE-SOLDER
K914186 · Dentsply Intl. · Dec 1991
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
K905761 · Argen Precious Metals, Inc. · Jan 1991
ARGENCO 52HN
K905811 · Argen Precious Metals, Inc. · Jan 1991