Manufacturer registered with FDA
Shenzhen Superline Technology Co Ltd
Shenzhen, China. Lists 11 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 11
- Brands and models
- 53
- 510(k) clearances
- 12025–2025
- Markets registered in
- 132,013 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Shenzhen Superline Technology Co Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shenzhen Superline Technology Co Ltd | 1 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 1,794 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 66 | 2025–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Shenzhen Superline Technology Co. Ltd. | 50 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTDSHENZHEN SUPERLINE TECHNOLOGY CO. LTD. | 30 | 2008–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Superline Technology Co Ltd | 18 | 2007–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.SHENZHEN SUPERLINE TECHNOLOGY CO.,LTD · Shenzhen Superline Technology Co., Ltd. · +2 | 17 | 2010–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 15 | 2025–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shenzhen Superline Technology Co. Ltd. | 9 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO LTD | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Shenzhen Superline Technology CO., LTDShenzhen Superline Technology Co. Ltd · Shenzhen Superline Technology Co. Ltd. · +1 | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 4 | 2016–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2 | 2022–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shenzhen Superline Technology Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DeltajetFliexNICROOT.XSuperfileTarget | 2010 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | DeltajetNICSuperfileTarget | 2010 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Diamond dental burs,NIC dental burs,SUPERLINE dental bursFliexZirconia cutting burs | 2025 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | DeltajetFliexNICROOT.XSuperfileTarget | 2010 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | FliexNICROOT.XSUPERFILE | 2019 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | FliexNICROOT.XSUPERFILE | 2019 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | DeltajetFliexNICROOT.XSuperfileTarget | 2010 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | DeltajetFliexNICObturation System(Alpha Fill-System, Alpha Fill-G, Alpha Fill-P)ROOT.XSuperfileTarget | 2010 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | DeltajetFliexNICROOT.XSuperfileTarget | 2010 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Maker | DeltajetFliexNICROOT.XSuperfileTarget | 2010 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Endo Handpiece, Endo Motor,Dental handpiece, Fliex | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN SUPERLINE TECHNOLOGY CO.,LTDFDA reg. 3008249935 | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031408). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.