Cleared Traditional

K844497 - AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY

K844497 is an FDA 510(k) clearance for AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY, 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 99-day FDA review.

K844497 · Austenal Dental, Inc. · Dental device
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Feb 1985
Decision
99d
Days
Class 2
Risk

K844497 is an FDA 510(k) clearance for the AUSTENAL A-79 CROWN & BRIDGE CASTING 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 27, 1985 after a review of 99 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 Austenal Dental, Inc. devices

FDA 510(k) Submission Details - K844497

510(k) Number K844497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1984
Decision Date February 27, 1985
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
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 K844497.
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
CERAMIC ALLOY NO. DW 179
K852895 · Williams Gold Refining Co., Inc. · Oct 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · Aalba Dent, Inc. · May 1985
RX CBG
K844122 · Jeneric Ind. · Jan 1985
RX CBY
K844123 · Jeneric Ind. · Jan 1985
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984