Registered with FDA
Unisource Shanghai Ltd.
Shanghai, China. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 32
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Unisource Shanghai 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | DENTAL MIRROR, DENTAL MOUTH MIRRORMirrorSoft No.5 Double MirrorMirrorSoft No.5 MirrorMirrorSoft TearDrop MirrorMirroSoft No.4 Mirror | 2011 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Lister | LED Headlight System | 2023 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Lister | Aligner ChewiesAligner Hook / Remover | 2022 |
| Roll CottonEFN · Class 1 | — | Lister | — | 2012 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Toothbrushes Adult & Kids | 2008 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Dental WaxOrthodontic Wax | 2021 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | Teeth Whitening Strips | 2023 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | Angle-Ease Ejector | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | Lock N ReloadRefill-Ease | 2025 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Scan-Mate (Black)Scan-Mate (Blue)Scan-Mate MegaGenTissuePro Distal Sleeve, MN RetractorTissuePro Distal Sleeve, MN Retractor Single-Use;TissuePro Proximal Sleeve, MN RetractorTissuePro Single Sleeve, MN Retrator | 2025 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Comfort Soft LargeComfort Soft SmallMouth MateTongue-Guide Infant HomeTongue-Guide Infant ProTongue-Guide Standard Pro | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Toothbrush Powered, Eletricity Toothbrush | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Dental Floss | 2008 |
| Tongue ScraperLCN · Class 1 | — | Lister | Tongue Scraper | 2018 |
| Over the Counter Wax Impregnated Cotton Denture Pad CushionNKJ · Class 1 | — | Lister | — | 2012 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Lister | Toothbrush Sanitizer | 2023 |
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 |
|---|---|---|
| UNISOURCE SHANGHAI LTD.FDA reg. 3007165189 | SHANGHAI, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027023). 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.