510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970205Substantially Equivalent

Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy

Austenal, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970205 is the FDA 510(k) clearance record for VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY, a class II device, cleared for Austenal, Inc. on under FDA product code EJH (Alloy, Metal, Base). FDA records list 10 510(k) clearances for Austenal, Inc., from to . As of , FDA records show no recalls naming K970205.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EJH Alloy, Metal, Base
Regulation
21 CFR 872.3710
Device class
Class II
Review panel
Dental
Applicant
Austenal, Inc. 4101 W. 51st St., Chicago IL
510(k) summary
Summary
Third party review
No

Clearances, product code EJH

Trailing 12 months

FDA records hold no clearances under product code EJH in the trailing twelve months.

FDA records show no clearances under product code EJH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260