Medical Device Manufacturer · US , Chicago , IL

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

19 submissions · 19 cleared · Since 1985
19
Total
19
Cleared
0
Denied

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

19 devices
1-19 of 19
Cleared Jul 14, 1989
OVERDENTURE - STUD ATTACHMENT
K890713 · DZE
Dental · 151d
Cleared Oct 20, 1988
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · EBI
Dental · 43d
Cleared Apr 07, 1988
VITALLIUM EQUIPOISE ALLOY
K880875 · EJH
Dental · 37d
Cleared Aug 10, 1987
LIGHT CURE DENTURE GLAZE
K871849 · EBI
Dental · 90d
Cleared Jul 21, 1987
VITALLIUM WIRE
K872746 · EJW
Dental · 8d
Cleared Mar 11, 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · EBI
Dental · 175d
Cleared Feb 19, 1987
AUSTENAL ACUSOFT SOFT LINER
K862557 · EBI
Dental · 231d
Cleared Feb 19, 1987
AUSTENAL CONDENSING INSTRUMENT
K865025 · EKG
Dental · 58d
Cleared Feb 10, 1987
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
K864826 · EJH
Dental · 63d
Cleared Aug 26, 1986
PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
K862856 · EJS
Dental · 28d
Cleared Jul 31, 1986
COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
K862667 · EJH
Dental · 17d
Cleared Jul 18, 1986
AUSTENAL ACUPAC HI DENTURE BASE MATERIAL
K862558 · EBI
Dental · 15d
Cleared Jul 03, 1986
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY
K862417 · EJH
Dental · 8d
Cleared Mar 26, 1986
AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL
K860911 · ELW
Dental · 15d
Cleared Mar 26, 1986
WHITE SILVER SOLDER AND YELLOW SILVER SOLDER
K860964 · EJS
Dental · 13d
Cleared Mar 17, 1986
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
K860217 · EJH
Dental · 54d
Cleared Jan 30, 1986
AUSTENAL DENTAL COMPOSITE RESIN
K854957 · EBD
Dental · 50d
Cleared Oct 31, 1985
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
K853160 · ELM
Dental · 93d
Cleared Feb 27, 1985
AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
K844497 · EJH
Dental · 99d
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