Manufacturer registered with FDA
Hubei Guarddent Medical Technology Co.,Ltd
Wuhan City, China. Lists 34 dental device types with FDA across 1 registered establishment.
- Device types listed
- 34
- Brands and models
- 37
- 510(k) clearances
- 0as applicant
- Markets registered in
- 737 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Hubei Guarddent Medical Technology Co.,Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hubei Guarddent Medical Technology Co.,Ltd | 34 device types | — | Below |
| European Union | EUDAMED | Manufacturer | HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD | 27 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD | 3 | 2025–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTDHUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTD. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTDHubei Guarddent Medical Technology Co., Ltd. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HUBEI GUARDDENT MEDICAL TECHNOLOGY CO., LTDHubei Guarddent Medical Technology Co. ,Ltd | 2 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Hubei Guarddent Medical Technology Co Ltd | 1 | 2024–2024 | 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 Hubei Guarddent Medical 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Saliva Ejectors | 2020 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Arch Wire | 2024 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental needle | 2021 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Wedges/Smart Dental WedgesGingival drainage | 2026 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | dental mouth mirror | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | denture teethImpression Trays, Bite Registration Tray | 2020 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air Water Syringe Tips | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Rubber Chain and Ligature Tie | 2024 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner Chewies | 2026 |
| Articulation PaperEFH · Class 1 | — | Maker | Articulating Paper | 2024 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Rolls | 2020 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrushes | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Dental Wax | 2024 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Dental Bib holdersPhosphor Plate | 2025 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy angle/cup/brush | 2022 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | High Volume HVE Tips | 2020 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Curved Syringe | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Pre Bent Needle Tips, Mixing Tips, irrigation syringe,dental needle | 2020 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | lmpression Syringe | 2020 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | rubber dam | 2026 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Mouth Prop | 2020 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Brackets | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | dental Burs | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta percha points | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent paper points | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Endo file | 2023 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Fiber Post | 2024 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Matrix Bands | 2024 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Retainer Storage Case/Retainer Box/Denture Box | 2026 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2024 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Patient Bibs | 2020 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Micro Applicator Brush, Mixing Wells | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dappen Dish/Mixing Spatulas | 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 |
|---|---|---|
| HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTDFDA reg. 3017910185 | Wuhan Hubei, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078958). 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.