Is this your brand? Sign in to claim ownership.
Sign in to claim this brandLUITPOLD PHARMACEUTICALS, INC.
US
Last updated May 30, 2026
What LUITPOLD PHARMACEUTICALS, INC. makes
Luiptold Pharmaceuticals, Inc. manufactures a periodontal root surface regeneration material marketed under the name GEM 21S. This product is intended for use in dental procedures to promote the regeneration of root surfaces affected by periodontal disease.
The GEM 21S device is classified as a Class II medical device and is listed in the FDA 510(k) database and the FDA Unique Device Identification (UDI) system. Luiptold Pharmaceuticals is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of medical device does Luiptold Pharmaceuticals, Inc. manufacture?
Luiptold Pharmaceuticals, Inc. produces a periodontal root surface regeneration material, which is a device used in dental procedures to help regenerate root surfaces that have been damaged by periodontal disease. This conclusion is drawn directly from the device category listed in the provided data.
Where is Luiptold Pharmaceuticals, Inc. headquartered?
The company is based in the United States, as indicated by the 'COUNTRY: US' entry in the source information. No other location is mentioned, so the U.S. is the only confirmed headquarters location.
In which regulatory listings can Luiptold's device be found?
The GEM 21S device is listed in the FDA 510(k) database and the FDA Unique Device Identification (UDI) system. This is explicitly stated under the 'LISTED IN' section, confirming that the device appears in both of those FDA registries.
How is the GEM 21S device classified under FDA regulations?
According to the data, GEM 21S is classified as a Class II medical device. Class II classification indicates that the device requires special controls in addition to general controls, which is the regulatory category assigned to this periodontal regeneration material.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- osteohealth.com
- —
- —
- [email protected]
- Phone
- 1-800-874-2334
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 002033710
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gem 21s | N/A | FDA UDI | N/A | Unknown |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Unknown |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Unknown |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Unknown |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Active |
| Gem 21s | N/A | FDA UDI | N/A | Unknown |
| Equimatrix | K111816 | FDA 510(k) | Class II | Active |
| Osteo-Pin Membrane Fixation Pin | K990537 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.