Manufacturer registered with FDA
Boen Healthcare Co Ltd
Suzhou, China. Lists 19 dental device types with FDA across 1 registered establishment.
- Device types listed
- 19
- Brands and models
- 22
- 510(k) clearances
- 0as applicant
- Markets registered in
- 795 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Boen Healthcare 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 | Boen Healthcare Co Ltd | 19 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Boen Healthcare Co.,Ltd | 73 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | BOEN HEALTHCARE CO., LTDBoen Healthcare Co., Ltd., | 12 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Boen Healthcare Co., Ltd.Boen Healthcare Co., Ltd | 7 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Boen Healthcare Co Ltd | 1 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BOEN HEALTHCARE CO., LTD. | 1 | 2020–2020 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Boen Healthcare 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 Boen Healthcare 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 | — | Lister | mouthpiece; saliva ejector | 2026 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental Needle, Dental Anesthesia Needle | 2026 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Choking Rescue DeviceFluid Fighter Suction Mat; Suction Mat; Suction Ring; Suction Ring With Tubing; Apparatus Suction; Suction CatheterKarl Hammacher GmbH | 1988 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Oral mirrorsdontoscope | 2026 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Dental Irrigation Syringe | 2026 |
| Roll CottonEFN · Class 1 | — | Maker | Absorbent Cotton Roll; Cotton Ball; Cotton Pad; Zig-Zag Cotton WoolCotton Roll; Dental Cotton Roll; Absorbent Cotton Wool; Absorbent Cotton Balls | 2026 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | Disposable irrigator | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Bamboo Toothbrush; Pet brush | 2026 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | Surgical scissors | 2026 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophylaxis Cup; Prophy Cup | 2026 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator; Oral Cavity; Surgical Aspirator Tip | 2026 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Dental Irrigating Syringe, Dental Irrigating Tips | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Disposable Tray; Kindney Tray; Medical Tray | 2026 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | forceps; rubber dam clamp | 2026 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Medical tweezers | 2026 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | dental bib | 2026 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Resin Applicator | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Blunt Tip Dispensing Needle | 2026 |
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Dental Kit; Hygiene Kit; Patient Admission Kit; Patient Personal Hygiene Kit; Protection Kit | 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 |
|---|---|---|
| BOEN HEALTHCARE CO., LTD.FDA reg. 3045058049 | Suzhou Jiangsu, China | Foreign exporter, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095691). 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.