FDA Registration
Active
🇨🇳 China
Envista (Suzhou) Medical Device Co., Ltd.
Reg #: 3014749460
·
FEI: 3014749460
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Envista (Suzhou) Medical Device Co., Ltd.
- Registration Number
- 3014749460
- FEI Number
- 3014749460
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1st floor 2nd floor Building 18#, No.8 Jinfeng Road
- City
- Suzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- SYBRON DENTAL SPECIALTIES, INC.
- Operator Number
- 9029565
- Address
- 1889 W Mission Blvd, --
- City
- Pomona
- State
- CA
- Postal Code
- 91766
- Country
- US
US Agent
- Business Name
- SYBRON DENTAL SPECIALTIES, INC.
- Contact Name
- Procoro Herrera
- Address
- Sybron Dental Specialties, Inc, 200 Kraemer Blvd
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 657 3416074
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2018-11-01 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 1982-12-15 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2021-04-20 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2023-11-17 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-12-20 |
Proprietary Names
Spark Clear Aligner System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)