Cleared Traditional

K970205 - VITALLIUM 2000 ALLOY

Also marketed or referenced as:
VITALLIUM 2000 PLUS ALLOY COBALT CHROME CASTING ALLOY

K970205 is an FDA 510(k) clearance for VITALLIUM 2000 ALLOY, manufactured by Austenal, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970205 · Austenal, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
90d
Days
Class 2
Risk

K970205 is an FDA 510(k) clearance for the VITALLIUM 2000 ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Austenal, Inc. (Chicago, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 90 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.

FDA 510(k) Submission Details - K970205

510(k) Number K970205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date April 21, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
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 138
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K970205.
VERABOND 2V
K973265 · Aalba Dent, Inc. · Oct 1997
PLATALLOY
K972607 · Aalba Dent, Inc. · Oct 1997
VERA PDN
K972118 · Aalba Dent, Inc. · Aug 1997
PRECISE
K970827 · Allan Schulman,D.D.S., M.S. · Apr 1997
RX 96E
K963891 · Jeneric/Pentron, Inc. · Nov 1996
CERAMCO CROWNS AND BRIDGES
K961720 · Eric S. Small, Dds · Jul 1996
K970205 · VITALLIUM 2000 ALLOY
Download PDF FDA Summary Austenal, Inc.