Cleared Traditional

K854738 - SPARTAN SOLDER

K854738 is an FDA 510(k) clearance for SPARTAN SOLDER, manufactured by Williams Gold Refining Co., Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K854738 · Williams Gold Refining Co., Inc. · Dental device
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Mar 1986
Decision
101d
Days
Class 2
Risk

K854738 is an FDA 510(k) clearance for the SPARTAN SOLDER. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Williams Gold Refining Co., Inc. (Buffalo, US). The FDA issued a Cleared decision on March 6, 1986 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 872.3710 - 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

FDA 510(k) Submission Details - K854738

510(k) Number K854738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1985
Decision Date March 06, 1986
Days to Decision 101 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
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 79
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K854738.
BIOSIL F
K861820 · Degussa Dental, Inc. · Jun 1986
BIOSIL H
K861787 · Degussa Dental, Inc. · May 1986
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
H40 BASE METAL ALLOY
K854878 · Jeneric Ind. · Jan 1986
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
CERAMIC ALLOY NO. DW 179
K852895 · Williams Gold Refining Co., Inc. · Oct 1985