Shenzhen Superline Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 12 device types, 3 products catalogued, 2 clearances.
Shenzhen Superline Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Gutta-Percha, Wire, Orthodontic and 10 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
12device types registered with the FDA
3products catalogued under its own name
2510(k) clearances
Registration
| Registered name | SHENZHEN SUPERLINE TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008249935 |
| FEI number | 3008249935 |
| DUNS | 527943851 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳速航科技股份有限公司 |
|---|---|
| Unified social credit code | 91440300738808671G |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 302, Nanshan Zhiyuan A4, No.1001 Xueyuan Avenue, Changyuan community, Taoyuan Street, Nanshan District |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Broach, Endodontic | Class 1 | Target, Deltajet, Superfile, NIC, Root.x, Fliex | 2010 | 10 |
| Drill, Dental, Intraoral | Class 1 | NIC, Deltajet, Superfile, Target, Fliex, Root.x | 2010 | 20 |
| File, Pulp Canal, Endodontic | Class 1 | Deltajet, Target, Superfile, NIC, Root.x, Fliex | 2010 | 53 |
| Gutta-Percha | Class 1 | NIC, Superfile, Root.x, Fliex | 2019 | 42 |
| Handpiece, Direct Drive, Ac-Powered | Class 1 | Endo Handpiece, Endo Motor,Dental handpiece, Fliex | 2025 | 10 |
| Instrument, Diamond, Dental | Class 1 | Fliex, Zirconia cutting burs, Diamond dental burs,NIC dental burs,SUPERLINE dental burs | 2025 | 7 |
| Locator, Root Apex | Class U | Fliex, Alpha Apex I, Electronic Apex Locator | 2025 | 8 |
| Plugger, Root Canal, Endodontic | Class 1 | Root.x, Obturation System(Alpha Fill-System, Alpha Fill-G, Alpha Fill-P), Deltajet, NIC, Target, Fliex and 1 more | 2010 | 19 |
| Point, Paper, Endodontic | Class 1 | NIC, Root.x, Superfile, Fliex | 2019 | 35 |
| Reamer, Pulp Canal, Endodontic | Class 1 | Superfile, Target, Deltajet, NIC, Root.x, Fliex | 2010 | 10 |
| Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | Fliex, NIC, Target, Superfile, Deltajet, Root.x | 2010 | 17 |
| Wire, Orthodontic | Class 1 | Superfile, Deltajet, Target, NIC | 2010 | 43 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| NIC or Superline | DZP | 7 |
| NIC/Superline | EKX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252223 | 2025-10-16 | EKX | Traditional | This company |
| K242765 | 2025-01-17 | LQY | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.