FDA Registration
Active
🇪🇸 Spain
Aligner secuential.
Reg #: 3022727952
·
FEI: 3022727952
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Xplora 3D Europe SL
- Registration Number
- 3022727952
- FEI Number
- 3022727952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE JUAN DE LA CIERVA 70. 28939 ARROYOMOLINOS
- City
- Madrid Madrid (Province)
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K210652
Owner / Operator
- Firm Name
- Microdental 2006 SL
- Operator Number
- 10087749
- Address
- CALLE JUAN DE LA CIERVA 70. 28939 ARROYOMOLINOS
- City
- Madrid
- State
- Madrid (Province)
- Postal Code
- 28939
- Country
- ES
- Correspondent
- Esther Aznar
US Agent
- Business Name
- Compliance4devices
- Contact Name
- Juan M Tezak
- Address
- 118 W Prive Cir
- City
- Delray Beach
- State
- FL
- ZIP
- 33445
- Country
- US
- [email protected]
- Phone
- 561 7892411
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2023-04-04 |
Proprietary Names
Aligner secuential.
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)