Registered with FDA
Astron Dental Corporation
Lake Zurich, IL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 51983–1987
- Markets registered in
- 45 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1980–2026
Registered in 4 markets
Where regulators' registries name Astron Dental Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Astron Dental Corporation | 5 clearances | 1983–1987 | Below |
| Australia | TGA | Manufacturer | Astron Dental Corporation | 2 | 2004–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Astron Dental | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Astron Dental Corporation | 1 | 2023–2023 | 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
Devices listed with FDA
What Astron Dental Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Astron LC Light Cure Base PlateAstron LC Light Cure Custom TrayAstron LC Light Cure Reline | 2008 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Lister | Duraclean Denture CleanerDuraclean II Denture Cleaner | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Astron Dental Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Dec 1987 | K874025 | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 10 Feb 1987 | K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 31 Jul 1985 | K852906 | DURACLEAN DENTURE CLEANER | JER Mechanical Denture Cleaner |
| 19 Jul 1984 | K833270 | ASTRON 77 INJECTION DENTURE RESIN | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jun 1983 | K831269 | VINYLAC PRESS-PACK DENTURE RESIN | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Keystone Industries (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ASTRON DENTAL CORPORATIONFDA reg. 1483306 | Lake Zurich, IL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1483306). 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.