Data / Medical devices / Germany / Alpha Dent Implants GMBH
Alpha Dent Implants GMBH: FDA-registered device maker in Pforzheim Baden-Wurttemberg, Germany, 3 510(k) clearances
Alpha Dent Implants GMBH is registered with the FDA (registration 3015383403) in Pforzheim Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015383403
- Address
- Hanauer strasse 1-5, Pforzheim Baden-Wurttemberg, Germany, 75181
- Owner or operator
- Alpha Dent Implants GmbH (10086730)
- Roles
- Manufacturer
- First device listed
- December 6, 2022
- Registered through
- 2026
- Brand names listed
- 4.5 L 13 Implant Superior Active 0 4.5 L 13, DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABP, Dental implant "Zahntium Implant", HCAEK Healing Cap for Aesthetic Abutment Konus, HCAEM Healing Cap for Angular Multi-Unit 17°/30°, HCAEM Healing Cap wide for Angular Multi-Unit 17°/30°, HCAEM- W Healing Cap wide for Angular Multi-Unit 17°/30°, HCWK 3/7 Wide Healing CAP 0 5.5 L 7.5 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2024 | K240435 | Alpha Dent Implants Dental Implants System | DZE | Substantially Equivalent | Alpha Dent Implants GmbH | accessdata.fda.gov |
| November 1, 2021 | K210499 | Alpha Dent Implants Dental Implants System | DZE | Substantially Equivalent | Alpha Dent Implants GmbH | accessdata.fda.gov |
| July 3, 2019 | K180968 | AlphaDent Implants Dental Implants System | DZE | Substantially Equivalent | Alphadent Implants, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated December 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.