Data / Medical devices / China / Shenzhen Superline Technology Co.,ltd
Shenzhen Superline Technology Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Superline Technology Co.,ltd is registered with the FDA (registration 3008249935) in Shenzhen Guangdong, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008249935
- Address
- Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan community, Taoyuan Street, Nanshan District, Shenzhen Guangdong, China, 518000
- Owner or operator
- SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. (10031408)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 25, 2010
- Registered through
- 2026
- Brand names listed
- Alpha Apex I, Deltajet, Diamond dental burs,NIC dental burs,SUPERLINE dental burs, Electronic Apex Locator, Endo Handpiece, Endo Motor,Dental handpiece, Fliex, Fliex, NIC, Obturation System(Alpha Fill-System, Alpha Fill-G, Alpha Fill-P) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Broach, Endodontic | EKW | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Manufacturer | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Manufacturer | accessdata.fda.gov |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2025 | K252223 | Alpha Endo Handpiece (Alpha Endo) | EKX | Substantially Equivalent | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | accessdata.fda.gov |
| January 17, 2025 | K242765 | Electronic Apex Locator (Alpha Apex I) | LQY | Substantially Equivalent | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | accessdata.fda.gov |
Compare with other makers
- All makers of Point, Paper, Endodontic
- All makers of Spreader, Pulp Canal Filling Material, Endodontic
- All makers of Drill, Dental, Intraoral
- All makers of Instrument, Diamond, Dental
- All makers of Plugger, Root Canal, Endodontic
- All makers of Gutta-Percha
Updated October 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.