Cleared Traditional

K860964 - WHITE SILVER SOLDER AND YELLOW SILVER SOLDER

K860964 is an FDA 510(k) clearance for WHITE SILVER SOLDER AND YELLOW SILVER S..., manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K860964 · Austenal Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
13d
Days
Class 2
Risk

K860964 is an FDA 510(k) clearance for the WHITE SILVER SOLDER AND YELLOW SILVER SOLDER. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on March 26, 1986 after a review of 13 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 Austenal Dental, Inc. devices

FDA 510(k) Submission Details - K860964

510(k) Number K860964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date March 26, 1986
Days to Decision 13 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
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

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 163
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K860964.
GDC 1830 CASTING ALLOY
K871288 · Deringer-Ney, Inc. · Apr 1987
DEGUPAL
K864162 · Degussa Dental, Inc. · Nov 1986
PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
K862856 · Austenal Dental, Inc. · Aug 1986
ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65
K855182 · Williams Gold Refining Co., Inc. · Mar 1986
DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS
K860439 · Williams Gold Refining Co., Inc. · Mar 1986
GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)
K860119 · Deringer-Ney, Inc. · Mar 1986