Not currently registered with FDA under this name
Lang Dental Manufacturing Co., Inc.
Wheeling, IL, United States. Named as applicant on 2 dental 510(k) clearances between 2016 and 2017. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22016–2017
- Markets registered in
- 311 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Lang Dental Manufacturing Co., 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 | Lang Dental Manufacturing Co., Inc. | 2 clearances | 2016–2017 | Below |
| European Union | EUDAMED | Manufacturer | Lang Dental Manufacturing Company, Inc. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Lang Dental Manufacturing Co Inc | 5 | 2012–2025 | 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 Lang Dental Manufacturing Co., Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 May 2017 | K163482 | Orthodontic Acrylic 2 | EBI Rebasing Repairing Relining Denture Resin |
| 2 Sep 2016 | K152981 | JET SET 4 DENTURE REPAIR RESIN | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Lang Dental Mfg. Co., Inc. (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.