Not currently registered with FDA under this name
Luitpold Pharmaceuticals, Inc.
Shirley, NY, United States. Named as applicant on 2 dental 510(k) clearances between 1999 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 21999–2011
- Markets registered in
- 33 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Luitpold Pharmaceuticals, 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 | Luitpold Pharmaceuticals, Inc. | 2 clearances | 1999–2011 | Below |
| South Korea | MFDS | Manufacturer | Luitpold Pharmaceuticals, Inc. | 2 | 2008–2011 | Pure Global AI |
| Israel | AMAR | Manufacturer | Luitpold Pharmaceuticals, Inc. | 1 | — | 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 Luitpold Pharmaceuticals, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Sep 2011 | K111816 | EQUIMATRIX | NPM Animal Source Bone Grafting Material |
| 19 Nov 1999 | K990537 | OSTEO-PIN MEMBRANE FIXATION PIN | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: NIBEC Co Ltd (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.