FDA Registration
Active
🇨🇳 China
AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro;
Reg #: 3015342395
·
FEI: 3015342395
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD.
- Registration Number
- 3015342395
- FEI Number
- 3015342395
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road, China (Shanghai) pilot free trade zone
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai Smartee Denti-Technology Co., Ltd.
- Operator Number
- 10060314
- Address
- 2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road, China (Shanghai) pilot free trade zone
- City
- Shanghai
- State
- CN-NOTA
- Postal Code
- 201210
- Country
- CN
- Correspondent
- Junfeng Yao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-10-30 |
Proprietary Names
AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro;
Owandy ios; Owandy ios Wireless; ST 200E
Establishment Types
Export Device to the United States But Perform No Other Operation on Device