Cleared Traditional

K864826 - A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)

K864826 is an FDA 510(k) clearance for A-SP ALLOY (SILVER-PALLADIUM CROWN & BR..., manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K864826 · Austenal Dental, Inc. · Dental device
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Feb 1987
Decision
63d
Days
Class 2
Risk

K864826 is an FDA 510(k) clearance for the A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 63 days - a notably fast clearance cycle.

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: 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 - K864826

510(k) Number K864826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date February 10, 1987
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 86
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K864826.
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
VITALLIUM EQUIPOISE ALLOY
K880875 · Austenal Dental, Inc. · Apr 1988
NPG NONPRECIOUS CROWN AND BRIDGE ALLOY
K863782 · Aalba Dent, Inc. · Nov 1986
REXILLIUM N. B. F.
K862822 · Jeneric Ind. · Sep 1986
RESISTAL P
K862870 · Degussa Dental, Inc. · Aug 1986