FDA Registration
Active
🇨🇿 Czechia
Take 1 Advanced Bite
Reg #: 3007743883
·
FEI: 3007743883
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SpofaDental a.s.
- Registration Number
- 3007743883
- FEI Number
- 3007743883
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Markova 238
- City
- Jicin Hradec Kralove
- Country
- CZ
Regulatory Submissions
- 510(k) Number
- K010994
Owner / Operator
- Firm Name
- SYBRON DENTAL SPECIALTIES, INC.
- Operator Number
- 9029565
- Address
- 1717 W. Collins Ave. Ca. 92867 USA, --
- City
- Orange
- State
- CA
- Postal Code
- 92867
- Country
- US
- Correspondent
- Jennifer Evans
US Agent
- Business Name
- Sybron Dental Specialities Inc.
- Contact Name
- Jennifer Evans
- Address
- 1717 West Collins Ave
- City
- Orange
- State
- CA
- ZIP
- 92867
- Country
- US
- [email protected]
- Phone
- 714 5167795
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2011-11-28 |
Proprietary Names
Take 1 Advanced Bite
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)