FDA Registration
Active
🇪🇸 Spain
ZIACOM IMPLANTS SLU
Reg #: 3013547803
·
FEI: 3013547803
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- ZIACOM IMPLANTS SLU
- Registration Number
- 3013547803
- FEI Number
- 3013547803
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- calle buhos 2
- City
- Pinto Madrid (Province)
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K182908
Owner / Operator
- Firm Name
- ZIACOM MEDICAL SLU
- Operator Number
- 10054858
- Address
- 2, calle buhos
- City
- Pinto
- State
- Madrid (Province)
- Postal Code
- 28320
- Country
- ES
- Correspondent
- Ana Isabel Garcia
US Agent
- Business Name
- Ruiz & Company
- Contact Name
- Humberto Ruiz
- Address
- 2385 Executive Center Drive,, Ste 100
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
- [email protected]
- Phone
- 561 4437191
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-01-30 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2020-01-30 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2025-09-17 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-01-30 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2017-05-05 |
Proprietary Names
CORVEN
Ziacom Zinic MT
Ziacom Zinic
Ziacom Zinic MTX
Ziacom Zinic SX
JOTA
Ziacom Instruments
Ziacom
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device