Manufacturer registered with FDA
Shandong Hengfeng Kerui Medical Equipment Co., Ltd
Qingdao City, China. Lists 19 dental device types with FDA across 1 registered establishment.
- Device types listed
- 19
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 47 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Shandong Hengfeng Kerui Medical Equipment 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 Hengfeng Kerui Medical Equipment Co., Ltd | 19 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shandong Hengfeng Kerui Medical Equipment Co., Ltd | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD | 2 | 2026–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shandong Hengfeng Kerui Medical Equipment Co., Ltd | 1 | 2026–2026 | 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 Hengfeng Kerui Medical Equipment 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wires (WIRE, ORTHODONTIC; Profa Wires) | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Chewing Gum, Torque Wrench, Locator Core Tool | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror | 2024 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner Chewies | 2024 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Device Unit, Oral Irrigation | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Manual Toothbrush | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic wax | 2024 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Hand Driver, Lab hex Driver, Multi-Unit Hex Driver, Locator-Core Tool | 2026 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Hand Dental Pluggers | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Burs (CARBIDE BURS, Dental Burs) | 2024 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points, Injectable Root Canal Sealer | 2024 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2024 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | EDTA Root Canal Lubrication Gel | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental Root Canal Instruments (Hand Files; Rotary files; Compactors; Enlargers; Paste Carrier; Barbed Broach) | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Dental scaler | 2024 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Powered Toothbrush | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Proxabrush/Proxy Brush; Soft Interdental Brush; Interdental Brush | 2024 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue Scraper | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Screw, Multi-Unit Screw, Implant Analog, Impression Coping, Scan Body, Healing Cap, Hand Driver,Lab hex Driver, Multi-Unit Hex Driver, Torque Wrench, Locator-Core Tool, Cover Cap | 2026 |
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 HENGFENG KERUI MEDICAL EQUIPMENT CO., LTDFDA reg. 3031191035 | Qingdao City Shandong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090457). 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.