Manufacturer registered with FDA
Fuzhou Delphin Bio-tech Co., Ltd.
Fuzhou, China. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Fuzhou Delphin Bio-tech 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 | Fuzhou Delphin Bio-tech Co., Ltd. | 12 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Fuzhou Delphin Bio-tech Co., Ltd. | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Fuzhou Delphin Bio-tech Co., Ltd. | 1 | — | 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 Fuzhou Delphin Bio-tech 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 |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Teeth whitening light | 2023 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton rolls | 2023 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | mouthwash tablets, Oil Pulling, Cleaning Crystals, Toothpaste Tablet, DSI Oil PullingMouthwash, mouth spray, denture cleansing tablets, mouth tray cleaner, aligner cleaner, cleaning tablets, | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Teeth wipe, toothbrush | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Dental mouthpiece, teeth whitening tray, anti-snore mouth guard, anti-grinding mouth guard, DSI Mouth TrayDSI Prophy Laxis Mouth Tray | 2023 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Gum protector gel | 2023 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek retractor | 2023 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Teeth shade guide | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric toothbrush | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental floss | 2023 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental bib | 2023 |
| Dental Stain EraserMAU · Class 1 | — | Maker | DSI Prophy Laxis Teeth Whitening Powder, DSI Teeth Whitening Strips, DSI ToothpastePurelyWHITE DELUXE Teeth Whitening Kit, PurelyWHITE Whitening Kit refill, MEANSMILE Teeth Whitening KitTeeth color corrector gel, teeth whitening pen, teeth whitening kit, teeth whitening foam, teeth whitening liquid,Teeth Remineralizing Gel, Teeth Desensitizing Gel, DSI Prophy Laxis Pasteteeth whitening gel, teeth whitening powder, teeth whitening toothpaste, teeth whitening strip | 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 |
|---|---|---|
| FUZHOU DELPHIN BIO-TECH CO., LTD.FDA reg. 3029507159 | Fuzhou Fujian, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088965). 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.