Austenal Dental, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K890713OVERDENTURE - STUD ATTACHMENTJuly 14, 1989
K883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINOctober 20, 1988
K880875VITALLIUM EQUIPOISE ALLOYApril 7, 1988
K871849LIGHT CURE DENTURE GLAZEAugust 10, 1987
K872746VITALLIUM WIREJuly 21, 1987
K863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIALMarch 11, 1987
K862557AUSTENAL ACUSOFT SOFT LINERFebruary 19, 1987
K865025AUSTENAL CONDENSING INSTRUMENTFebruary 19, 1987
K864826A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)February 10, 1987
K862856PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTORAugust 26, 1986
K862667COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOYJuly 31, 1986
K862558AUSTENAL ACUPAC HI DENTURE BASE MATERIALJuly 18, 1986
K862417NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOYJuly 3, 1986
K860911AUSTENAL HYCO ALGINATE IMPRESSION MATERIALMarch 26, 1986
K860964WHITE SILVER SOLDER AND YELLOW SILVER SOLDERMarch 26, 1986
K860217NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)March 17, 1986
K854957AUSTENAL DENTAL COMPOSITE RESINJanuary 30, 1986
K853160AUSTENAL MODIFIED ACRYLIC DENTURE RESINOctober 31, 1985
K844497AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOYFebruary 27, 1985