Manufacturer registered with FDA
Shanghai Lions Industrial Co., Ltd.
SHANGHAI, China. Lists 32 dental device types with FDA across 1 registered establishment.
- Device types listed
- 32
- Brands and models
- 51
- 510(k) clearances
- 0as applicant
- Markets registered in
- 418 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Shanghai Lions Industrial Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shanghai Lions Industrial Co., Ltd. | 32 device types | — | Below |
| European Union | EUDAMED | Manufacturer | SHANGHAI LIONS INDUSTRIAL CO.,LTD | 14 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Shanghai Lions Industrial Co., Ltd.Shanghai Lions Industrial Co.,Ltd | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Lions Industrial Co.,Ltd | 1 | 2024–2024 | 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 Shanghai Lions Industrial 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | mouthpiece, saliva ejector | 2024 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | dental Irrigation needle/tipsDisposable Dental Needles | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | instruments, dental hand, disposable Irrigation needles, Plastic wedge, wooden wedge | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Cheek retractorDisposable Dental kits (probe, mirror, tweezer)Disposable mirrorMIRROR, MOUTHPhoto contrast boardScissors | 2024 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Dental simulatorTeeth model | 2025 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air water syringe tipUNIT, SYRINGE, AIR AND/OR WATER | 2024 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | aligner, bracket, orthodontic | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | wax, dental, intraoral | 2024 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | BITE WING TABS | 2026 |
| X-Ray CollimatorEHB · Class 1 | — | Maker | X ray sensor holder | 2025 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | cup, prophylaxisProphy angleProphy brush, prophy cup | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | tray, impression, preformed | 2024 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | evacuator, oral cavity | 2024 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Dental delivery tipsDental dispenser syringeDispenser gunMixing tips | 2025 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Endo measurement block | 2025 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Denture boxretainer box | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental diamond bur | 2025 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | Polishing strips | 2025 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophy paste | 2025 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | gutta-percha | 2024 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | point, paper, endodontic | 2024 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Matrix bands | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | floss, dental | 2024 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental bib | 2025 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Dental splint | 2025 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Applicator Resin, prebent tipsdental Composite brush | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Orthodontic kit | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barrier filmdisposable Dental evacuation trapsDisposable plastic sleeves/coversunit, operative dental, accessories | 2024 |
| Lapping Tool KitNYG · Class 1 | Dental hand instruments | Maker | Air prophy unitDiamond grinting head | 2025 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | Endo bur holder/cleanser | 2025 |
| Oral Surgery TrayPWL · Class 1 | Dental hand instruments | Maker | Mixing pad | 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 |
|---|---|---|
| SHANGHAI LIONS INDUSTRIAL CO.,LTD.FDA reg. 3031582434 | SHANGHAI, China | Contract manufacturer, Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090728). 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.