# Hubei Guarddent Medical Technology Co.,Ltd (manufacturer, Wuhan Hubei, CN): 10 new FDA device listings, incl. cleaner, denture, mechanical

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Hubei Guarddent Medical Technology Co.,Ltd |
| Role | Manufacturer |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device |
| Location | Wuhan Hubei, CN |
| New listings | 10 |
| Devices | Cleaner, Denture, Mechanical; Tape, Measuring, Rulers And Calipers; Handle, Scalpel; Pusher, Band, Orthodontic; Instrument, Manual, Surgical, General Use; Mixer, Cement, For Clinical Use; Dental Barriers And Sleeves; Unit, Operative Dental, Accessories; Syringe, Irrigating (Dental); Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Product codes | JER, FTY, GDZ, ECS, MDM, JDZ, PEM, NRD, EIB, HOY |
| Device classes | Class I, Class II |
| Medical specialties | Dental, General, Plastic Surgery, Orthopedic, Ophthalmic |
| Brand names | Retainer Storage Case/Retainer Box/Denture Box; Dental Endodontic File Holder; Scalpel Handle; Aligner Chewies; Instrument Disinfection Box; Dental Mixing Bowl/Mixing Wells; Dental Barrier and Sleeves; Dappen Dish/Mixing Spatulas |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-07-23 |
| FDA registration number | 3017910185 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.