Hubei Guarddent Medical Technology Co., Ltd.
Registered establishment in Wuhan, Hubei, China. 60 device types.
Hubei Guarddent Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Finger Cot, Bur, Dental and 58 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | HUBEI GUARDDENT MEDICAL TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017910185 |
| FEI number | 3017910185 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Wuhan |
|---|---|
| Province | Hubei |
| Address | Room 24-29th, 2/F, No. 11 Block, No.1 Guiyuan Temple South Road, Hanyang District |
| Postal code | 430070 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Patient Bibs | 2020 | 86 |
| Accessories, Retractor, Dental | Class 1 | Mouth Prop | 2020 | 37 |
| Accessory, Surgical Apparel | Class 1 | Face Shield | 2020 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Applicators | 2020 | 186 |
| Applicator, Resin | Class 1 | Micro Applicator Brush, Mixing Wells | 2020 | 24 |
| Band, Elastic, Orthodontic | Class 1 | Orthodontic Rubber Chain and Ligature Tie | 2024 | 36 |
| Bedding, Disposable, Medical | Class 1 | disposable sheet | 2022 | 308 |
| Blade, Scalpel | Class 1 | Blade | 2023 | 41 |
| Bracket, Metal, Orthodontic | Class 1 | Orthodontic Brackets | 2024 | 52 |
| Bur, Dental | Class 1 | dental Burs | 2026 | 46 |
| Cap, Surgical | Class 1 | Bouffant Caps | 2020 | 178 |
| Chair, Examination And Treatment | Class 1 | Barrier covers, Barrier film | 2020 | 23 |
| Cleaner, Denture, Mechanical | Class 1 | Retainer Storage Case/Retainer Box/Denture Box | 2026 | 12 |
| Cotton, Roll | Class 1 | Cotton Rolls | 2020 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Covers | 2020 | 176 |
| Cup, Prophylaxis | Class 1 | Prophy angle/cup/brush | 2022 | 49 |
| Dam, Rubber | Class 1 | rubber dam | 2026 | 23 |
| Dental Barriers And Sleeves | Class 2 | Dental Barrier and Sleeves | 2026 | 12 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue depressor | 2023 | 100 |
| Dispenser, Solid Medication | Class 1 | Barrier Film Dispenser, Cotton Rolls Dispenser | 2020 | 68 |
| Evacuator, Oral Cavity | Class 1 | High Volume HVE Tips | 2020 | 49 |
| File, Pulp Canal, Endodontic | Class 1 | Endo file | 2023 | 53 |
| Finger Cot | Class 1 | Hygienic Finger Cots | 2024 | 29 |
| Floss, Dental | Class 1 | Dental Floss | 2024 | 151 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Nonwoven Gauze | 2020 | 266 |
| Gown, Surgical | Class 2 | surgical gowns | 2025 | 68 |
| Gutta-Percha | Class 1 | Gutta percha points | 2023 | 42 |
| Handle, Scalpel | Class 1 | Scalpel Handle | 2026 | 29 |
| Holder, Film, X-Ray | Class 1 | Phosphor Plate, Dental Bib holders | 2025 | 40 |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Self Sealing Sterilization Pouches | 2022 | 19 |
| Instrument, Manual, Surgical, General Use | Class 1 | Instrument Disinfection Box | 2026 | 110 |
| Instruments, Dental Hand | Class 1 | Dental Wedges/Smart Dental Wedges, Gingival drainage | 2026 | 64 |
| Mask, Surgical | Class 2 | face masks | 2025 | 125 |
| Material, Impression Tray, Resin | Class 1 | Impression Trays, Bite Registration Tray, denture teeth | 2020 | 41 |
| Mirror, Mouth | Class 1 | dental mouth mirror | 2022 | 94 |
| Mixer, Cement, For Clinical Use | Class 1 | Dental Mixing Bowl/Mixing Wells | 2026 | 14 |
| Mouthpiece, Saliva Ejector | Class 1 | Saliva Ejectors | 2020 | 68 |
| Needle, Dental | Class 1 | Dental needle | 2021 | 56 |
| Non-Surgical Gown | Class 1 | lsolation Gowns, Surgical Gown | 2020 | 318 |
| Paper, Articulation | Class 1 | Articulating Paper | 2024 | 12 |
| Point, Paper, Endodontic | Class 1 | Absorbent paper points | 2023 | 35 |
| Post, Root Canal | Class 1 | Fiber Post | 2024 | 10 |
| Protector, Dental | Class 1 | Dental block | 2023 | 11 |
| Pusher, Band, Orthodontic | Class 1 | Aligner Chewies | 2026 | 12 |
| Retainer, Matrix | Class 1 | Matrix Bands | 2024 | 13 |
| Retainer, Surgical | Class 1 | Retainer Box,Denture box | 2020 | 10 |
| Retractor, All Types | Class 1 | Cheek Retractor | 2022 | 45 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Safety Glasses, Handheld Light Protective Shield | 2026 | 384 |
| Syringe, Irrigating (Dental) | Class 1 | Curved Syringe | 2026 | 22 |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | Pre Bent Needle Tips, Mixing Tips, irrigation syringe,dental needle | 2020 | 32 |
| Syringe, Restorative And Impression Material | Class 1 | lmpression Syringe | 2020 | 49 |
| Tape And Bandage, Adhesive | Class 1 | Cohesive tape/self adhesive bandage wrap | 2022 | 353 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Dental Endodontic File Holder | 2026 | 42 |
| Toothbrush, Manual | Class 1 | Toothbrushes | 2024 | 244 |
| Tray, Surgical, Instrument | Class 1 | Plastic Instrument Trays | 2020 | 105 |
| Unit, Operative Dental, Accessories | Class 1 | Dappen Dish/Mixing Spatulas | 2026 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | Air Water Syringe Tips | 2020 | 56 |
| Wax, Dental, Intraoral | Class 1 | Dental Wax | 2024 | 55 |
| Wire, Orthodontic | Class 1 | Orthodontic Arch Wire | 2024 | 43 |
| Wrap, Sterilization | Class 2 | Self Sealing Sterilization Pouches | 2022 | 38 |
Clearances
No clearance names Hubei Guarddent Medical Technology Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233918 | 2024-05-09 | PEM | Traditional | Yongqing Huaguan Dental Instruments Factory |
| K212718 | 2022-01-12 | FYA | Traditional | Xiantao Dingcheng Non-Woven Product Co., Ltd. |
| K212344 | 2021-11-16 | FXX | Traditional | Xiantao Dingcheng Non-Woven Product Co., Ltd. |
| K162258 | 2017-04-28 | FRG | Traditional | Tianchang Jiarui Packaging Material Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Employees | 320 |
| Factory area | 40000 |
| Main products | Dental disposable items, Impression and restoration trays, Evacuation products, Infection control supplies, Endodontic supplies |
| Certifications | ISO 13485, CE, FDA |
| Export markets | North America, Europe, Asia, South America, Mid-East (60+ countries) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.