Wellmed Dental Medical Supply Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 37 device types, 3 clearances.
Wellmed Dental Medical Supply Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Gutta-Percha, Apron, Leaded and 35 other device types. Its earliest product listing with the FDA dates from 2014.
37device types registered with the FDA
3510(k) clearances
Registration
| Registered name | Wellmed Dental Medical Supply Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010598169 |
| FEI number | 3010598169 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 301 Zhongxing Science and Technology Building |
| Postal code | CN-44 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Accessory, Surgical Apparel | 2015 | 439 |
| Aligner, Bracket, Orthodontic | Class 1 | Aligner, Bracket, Orthodontic | 2023 | 30 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Applicator, Absorbent Tipped, NON-Sterile | 2014 | 186 |
| Applicator, Resin | Class 1 | Applicator Resin | 2021 | 24 |
| Apron, Leaded | Class 1 | Apron, leaded | 2015 | 6 |
| Bedding, Disposable, Medical | Class 1 | Bedding, Disposable, Medical | 2015 | 308 |
| Cap, Surgical | Class 1 | CAP, Surgical | 2015 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, Operating-Room | 2015 | 176 |
| Cup, Prophylaxis | Class 1 | CUP, Prophylaxis | 2014 | 49 |
| Dental Barriers And Sleeves | Class 2 | Dental Barrier and Sleeves | 2024 | 12 |
| Dispenser, Solid Medication | Class 1 | Dispenser, solid medication | 2014 | 68 |
| Drape, Surgical, Exempt | Class 2 | Dental Barrier and Sleeves | 2024 | 107 |
| Evacuator, Oral Cavity | Class 1 | Evacuator, Oral Cavity | 2014 | 49 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask | 2020 | 182 |
| Fiber, Medical, Absorbent | Class 1 | Fiber, Medical, Absorbent | 2015 | 172 |
| Floss, Dental | Class 1 | Floss, Dental | 2023 | 151 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze/sponge,nonresorbable for external use | 2015 | 266 |
| Gown, Examination | Class 1 | Gown, Examination | 2015 | 109 |
| Gutta-Percha | Class 1 | Gutta-Percha | 2023 | 42 |
| Indicator, Physical/Chemical Sterilization Process | Class 2 | Self Sealing Sterilization Pouches | 2025 | 19 |
| Instrument, Surgical, Disposable | Class 1 | Instrument, Surgical, Disposable | 2014 | 45 |
| Instruments, Dental Hand | Class 1 | Instruments, Dental Hand | 2014 | 64 |
| Mask, Scavenging | Class 1 | Disposable Mask | 2019 | 158 |
| Mask, Surgical | Class 2 | Disposable Medical Face Mask (DF3-001) | 2022 | 125 |
| Mirror, Mouth | Class 1 | Mirror, Mouth | 2023 | 94 |
| Mouthpiece, Saliva Ejector | Class 1 | Mouthpiece, Saliva Ejector | 2014 | 68 |
| Needle, Dental | Class 1 | Disposable Dental Needles | 2019 | 56 |
| Non-Surgical Gown | Class 1 | 2020 | 318 | |
| Point, Paper, Endodontic | Class 1 | Point, Paper, Endodontic | 2023 | 35 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Face Shield | 2020 | 384 |
| Toothbrush, Manual | Class 1 | Toothbrush | 2021 | 244 |
| Tray, Impression, Preformed | Class 1 | Tray, Impression, Preformed | 2014 | 73 |
| Tray, Surgical | Class 1 | Tray, Surgical | 2014 | 36 |
| Unit, Operative Dental, Accessories | Class 1 | Unit, Operative Dental, Accessories | 2015 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | Unit, Syringe, AIR AND/OR Water | 2014 | 56 |
| Wax, Dental, Intraoral | Class 1 | WAX, Dental, Intraoral | 2023 | 55 |
| Wrap, Sterilization | Class 2 | Self Sealing Sterilization Pouches | 2025 | 38 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243721 | 2025-04-25 | FRG | Traditional | This company |
| K242435 | 2024-10-18 | PEM | Traditional | This company |
| K222697 | 2022-11-04 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Dental disposables, Medical consumables, Air-water syringe tips, Saliva ejectors, Face masks, Protective gowns |
|---|
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.