Manufacturer registered with FDA
Shandong Richsource Biological Technology Co.,Ltd
Jining, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 25 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shandong Richsource Biological 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 | Shandong Richsource Biological Technology Co.,Ltd | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shandong Richsource Biological Technology Co.,Ltd | 5 | — | 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 Shandong Richsource Biological 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Orthodontic Bite Stick, Dental Braces Extractor | 2021 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Water Floss, Water Toothpick | 2021 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Interdental Brush, Toothbrush, Toothpaste Extruder, Bamboo Interdental Brush, Bamboo Toothbrush | 2021 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Dental Guard | 2023 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Ultrasonic Electric Dental Scaler (KWJ-103) | 2026 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush | 2021 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss Pick, Dental Floss, Bamboo Floss Picks | 2021 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Soft Pick | 2021 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue Scraper | 2021 |
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 |
|---|---|---|
| SHANDONG RICHSOURCE BIOLOGICAL TECHNOLOGY CO.,LTDFDA reg. 3021245739 | Jining Shandong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083252). 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.