Cleared Traditional

ALLOY 7 (K852093) - FDA 510(k) Clearance

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

K852093 · Williams Gold Refining Co., Inc. · Dental device
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Aug 1985
Decision
101d
Days
Class 2
Risk

K852093 is an FDA 510(k) clearance for the ALLOY 7. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Williams Gold Refining Co., Inc. (Buffalo, US). The FDA issued a Cleared decision on August 23, 1985 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Williams Gold Refining Co., Inc. devices

Submission Details

510(k) Number K852093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1985
Decision Date August 23, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 24
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K852093.
ARGENCO III
K903009 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 34
K903060 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE
K902665 · Argen Precious Metals, Inc. · Aug 1990
CERAMCO * HIGH FUSING FOIL SOLDER
K833434 · Johnson & Johnson Professionals, Inc. · Dec 1983
T-IV ELITE ALLOY
K820530 · Howmedica Corp. · Mar 1982
CLASS OF CASTING ALLOYS TYPE I OR ALTER
K820432 · Howmedica Corp. · Mar 1982