FDA Registration
Active
🇨🇳 China
SHENZHEN SUPERLINE TECHNOLOGY CO.,LTD
Reg #: 3008249935
·
FEI: 3008249935
·
Expires 2026
Products
12
Proprietary Names
12
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- SHENZHEN SUPERLINE TECHNOLOGY CO.,LTD
- Registration Number
- 3008249935
- FEI Number
- 3008249935
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan community, Taoyuan Street, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K252223
Owner / Operator
- Firm Name
- SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
- Operator Number
- 10031408
- Address
- Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan community, Taoyuan Street, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Sara Lai
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2010-01-25 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2025-12-04 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2010-01-25 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2010-01-25 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2019-06-04 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2019-06-04 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2010-01-25 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2010-09-18 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2025-04-01 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2010-01-25 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 2010-01-25 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2025-02-20 |
Proprietary Names
Obturation System(Alpha Fill-System, Alpha Fill-G, Alpha Fill-P)
Fliex
ROOT.X
Deltajet
Superfile
Target
NIC
Endo Handpiece, Endo Motor,Dental handpiece, Fliex
SUPERFILE
Diamond dental burs,NIC dental burs,SUPERLINE dental burs
Alpha Apex I
Electronic Apex Locator
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)