Medical Device Manufacturer · US , Chicago , IL

Austenal Dental, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1985

Recent clearances: OVERDENTURE - STUD ATTACHMENT, BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN, VITALLIUM EQUIPOISE ALLOY

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Austenal Dental, Inc. Dental ✕

19 devices

1-12 of 19

Cleared Jul 14, 1989

OVERDENTURE - STUD ATTACHMENT

Cleared Oct 20, 1988

BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN

Cleared Apr 07, 1988

VITALLIUM EQUIPOISE ALLOY

Cleared Aug 10, 1987

LIGHT CURE DENTURE GLAZE

Cleared Jul 21, 1987

Cleared Mar 11, 1987

AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL

Cleared Feb 19, 1987

AUSTENAL ACUSOFT SOFT LINER

Cleared Feb 19, 1987

AUSTENAL CONDENSING INSTRUMENT

Cleared Feb 10, 1987

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

Cleared Aug 26, 1986

PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR

Cleared Jul 31, 1986

COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY

Cleared Jul 18, 1986

AUSTENAL ACUPAC HI DENTURE BASE MATERIAL