FDA Registration
Active
🇪🇸 Spain
ZARC4ENDO
Reg #: 3019741877
·
FEI: 3019741877
·
Expires 2026
Products
9
Proprietary Names
42
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- ZARC4ENDO
- Registration Number
- 3019741877
- FEI Number
- 3019741877
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle Concejo de Tapia de Casariego, 1- Loc
- City
- GIJON Asturias
- Country
- ES
Owner / Operator
- Firm Name
- Zarc4Endo S.A.
- Operator Number
- 10085865
- Address
- Calle Concejo de Tapia de Casariego, 1- Local
- City
- GIJÓN
- State
- Asturias
- Postal Code
- 33204
- Country
- ES
- Correspondent
- MARIA JOSE CALDERON DIEZ
US Agent
- Business Name
- NuSmile LTD
- Contact Name
- Diane Johnson Krueger
- Address
- 3315 W. 12th Street
- City
- Houston
- State
- TX
- ZIP
- 77008
- Country
- US
- [email protected]
- Phone
- 713 8610033
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2022-08-24 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2022-08-24 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2022-08-24 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2022-08-24 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2022-08-24 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2022-10-27 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2022-08-24 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2022-08-24 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2022-08-24 |
Proprietary Names
Z-UP System
Z Micro-Opener
Z Micro-Shaper
Z-DOWN System
Paper Points Excalibur
Paper Points Zarc
Paper Points ApicalShaper
Paper Points Z-Fit
Paper Points BlueShaper
Paper Points SlimShaper
Paper Points NanoShaper
NiTi files BlueShaper
NiTi files Z-Condensor
NiTi files Excalibur
NiTi files BlueShaper PRO
NiTi RetreatAll
NiTi files Z-Glider
Z-Plugger
K Flex
NiTi files ApicalShaper
Hedstroem File
NiTi files SlimShaper
C+ File
NiTi files NanoShaper
K File
NiTi files Excalibur Glider PRO
NiTi files Z-Glider EVO
NiTi files Excalibur Glider
NiTi files SlimShaper PRO
NiTi files Excalibur PRO
Z-Activator
Endo-Block Ruler
Z-Gauge Ruler
Z-Rinse
Z-EVO
Gutta-Percha ApicalShaper
Gutta-Percha SlimShaper
Gutta-Percha BlueShaper
Gutta-Percha Zarc
Gutta-Percha NanoShaper
Gutta-Percha Excalibur
Gutta-Percha Z-Fit
Establishment Types
Foreign Private Label Distributor
Develop Specifications But Do Not Manufacture At This Facility