Not currently registered with FDA under this name
Austenal, Inc.
Chicago, IL, United States. Named as applicant on 10 dental 510(k) clearances between 1992 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 101992–2001
- Markets registered in
- 25 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Austenal, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Austenal, Inc. | 10 clearances | 1992–2001 | Below |
| South Korea | MFDS | Manufacturer | Austenal, Inc. | 5 | 1999–1999 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Austenal, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Sep 2001 | K011674 | DC - CRISTAL | EIH Porcelain Powder |
| 10 Aug 2000 | K001815 | DC ZIRKON | EIH Porcelain Powder |
| 10 Aug 2000 | K001799 | DC-TELL | EBF Resin Tooth Shade Material |
| 31 Jul 2000 | K001798 | DC TITAN | EJH Base Metal Alloy |
| 14 May 1997 | K970522 | MYERSON'S ECONOMY DENTURE BASE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 21 Apr 1997 | K970205 | VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY | EJH Base Metal Alloy |
| 28 Dec 1995 | K955509 | MIDAS GOLD ELECTROFORMING SYSTEM | EJT Gold-Based Noble Metal Alloy |
| 29 Nov 1995 | K954810 | MYERSON IR DENTURE BASE | EBI Rebasing Repairing Relining Denture Resin |
| 5 Jan 1994 | K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 4 Nov 1992 | K924526 | DENTURE PLASTIC TEETH | ELM Teeth Plastic Denture |
Some of these clearances are listed with FDA today by another company: The Myerson Company Limited (2), Myerson LLC (1).
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.