Data / Medical devices / Spain / Ziacom Implants Slu
Ziacom Implants Slu: FDA-registered device maker in Pinto Madrid(Province), Spain, 1 510(k) clearance
Ziacom Implants Slu is registered with the FDA (registration 3013547803) in Pinto Madrid(Province), Spain. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013547803
- Address
- calle buhos 2, Pinto Madrid(Province), Spain, 28320
- Owner or operator
- ZIACOM MEDICAL SLU (10054858)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- May 5, 2017
- Registered through
- 2026
- Brand names listed
- CORVEN, JOTA, Ziacom, Ziacom Instruments, Ziacom Zinic, Ziacom Zinic MT, Ziacom Zinic MTX, Ziacom Zinic SX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 18, 2019 | K182908 | Ziacom Dental Implant Systems | DZE | Substantially Equivalent | Ziacom Medical, S.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Disk, Abrasive
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Bur, Dental
Updated July 18, 2019. 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.