Manufacturer registered with FDA
Wellmed Dental Medical Supply Co., Ltd.
Shenzhen, China. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 9631 registrations outside the US
- Establishments
- 1China
Registered in 9 markets
Where regulators' registries name Wellmed Dental Medical Supply 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 | Wellmed Dental Medical Supply Co., Ltd. | 16 device types | — | Below |
| European Union | EUDAMED | Manufacturer | WELLMED DENTAL MEDICAL SUPPLY CO.,LTD | 526 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Wellmed Dental Medical Supply Co Ltd | 54 | 2018–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Wellmed Dental Medical Supply Co., Ltd | 30 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | WELLMED DENTAL MEDICAL SUPPLY Co., Ltd.WELLMED DENTAL MEDICAL SUPPLY CO., LTD. | 8 | 2022–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | WELLMED DENTAL MEDICAL SUPPLY CO., LTD | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Wellmed Dental Medical supply Co.LtdWellmed Dental Medical Supply Co., Ltd | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | WELLMED DENTAL MEDICAL SUPPLY CO., LTD | 2 | 2015–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Wellmed Dental Medical Supply Co., Ltd. | 1 | 2023–2023 | 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 Wellmed Dental Medical Supply 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 | MOUTHPIECE, SALIVA EJECTOR | 2014 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | Disposable Dental Needles | 2019 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | INSTRUMENTS, DENTAL HAND | 2014 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 2023 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | UNIT, SYRINGE, AIR AND/OR WATER | 2014 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | ALIGNER, BRACKET, ORTHODONTIC | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush | 2021 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | WAX, DENTAL, INTRAORAL | 2023 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | CUP, PROPHYLAXIS | 2014 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TRAY, IMPRESSION, PREFORMED | 2014 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | EVACUATOR, ORAL CAVITY | 2014 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | GUTTA-PERCHA | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | POINT, PAPER, ENDODONTIC | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | FLOSS, DENTAL | 2023 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Applicator Resin | 2021 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | UNIT, OPERATIVE DENTAL, ACCESSORIES | 2015 |
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 |
|---|---|---|
| Wellmed Dental Medical Supply Co., LtdFDA reg. 3010598169 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047916). 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.