Not currently registered with FDA under this name
Austenal Dental, Inc.
Chicago, IL, United States. Named as applicant on 19 dental 510(k) clearances between 1985 and 1989. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 191985–1989
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Austenal Dental, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Jul 1989 | K890713 | OVERDENTURE - STUD ATTACHMENT | DZE Root-Form Endosseous Implant |
| 20 Oct 1988 | K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 7 Apr 1988 | K880875 | VITALLIUM EQUIPOISE ALLOY | EJH Base Metal Alloy |
| 10 Aug 1987 | K871849 | LIGHT CURE DENTURE GLAZE | EBI Rebasing Repairing Relining Denture Resin |
| 21 Jul 1987 | K872746 | VITALLIUM WIRE | EJW Wire Clasp |
| 11 Mar 1987 | K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 19 Feb 1987 | K865025 | AUSTENAL CONDENSING INSTRUMENT | EKG Operative Amalgam and Foil Condenser |
| 19 Feb 1987 | K862557 | AUSTENAL ACUSOFT SOFT LINER | EBI Rebasing Repairing Relining Denture Resin |
| 10 Feb 1987 | K864826 | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) | EJH Base Metal Alloy |
| 26 Aug 1986 | K862856 | PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR | EJS Alloy Other Noble Metal |
| 31 Jul 1986 | K862667 | COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY | EJH Base Metal Alloy |
| 18 Jul 1986 | K862558 | AUSTENAL ACUPAC HI DENTURE BASE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 3 Jul 1986 | K862417 | NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY | EJH Base Metal Alloy |
| 26 Mar 1986 | K860964 | WHITE SILVER SOLDER AND YELLOW SILVER SOLDER | EJS Alloy Other Noble Metal |
| 26 Mar 1986 | K860911 | AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL | ELW Impression Material |
| 17 Mar 1986 | K860217 | NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY) | EJH Base Metal Alloy |
| 30 Jan 1986 | K854957 | AUSTENAL DENTAL COMPOSITE RESIN | EBD Resin Filling Material Coating |
| 31 Oct 1985 | K853160 | AUSTENAL MODIFIED ACRYLIC DENTURE RESIN | ELM Teeth Plastic Denture |
| 27 Feb 1985 | K844497 | AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY | EJH Base Metal Alloy |
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.