Manufacturer registered with FDA
Hefei Mlush Sanitary Products Co., Ltd
Hefei, China. Lists 20 dental device types with FDA across 1 registered establishment.
- Device types listed
- 20
- Brands and models
- 21
- 510(k) clearances
- 0as applicant
- Markets registered in
- 763 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Hefei Mlush Sanitary Products 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 | Hefei Mlush Sanitary Products Co., Ltd | 20 device types | — | Below |
| Colombia | INVIMA | Manufacturer | HEFEI MLUSH SANITARY PRODUCTS CO., LTD | 43 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hefei Mlush Sanitary Products Co., Ltd | 11 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hefei Mlush Sanitary Products Co.,LTD | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HEFEI MLUSH SANITARY PRODUCTS CO.,LTD | 3 | 2018–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | HEFEI MLUSH SANITARY PRODUCTS | 1 | 2017–2017 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HEFEI MLUSH SANITARY PRODUCTS CO., LTD. | 1 | 2019–2019 | 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 Hefei Mlush Sanitary Products 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 ejector,suction tips | 2015 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Speed Handpiece | 2018 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | dental needles /Irrigation Needlesealant cement | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Wedges | 2018 |
| Articulation PaperEFH · Class 1 | — | Maker | Articulating Paper | 2025 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | dental kit | 2015 |
| Roll CottonEFN · Class 1 | — | Maker | cotton rolls | 2015 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | polish brush/cup/ prophy angle | 2018 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | sani tip | 2018 |
| Irrigating (Dental) SyringeEIB · Class 1 | Dental hand instruments | Maker | Dental Curved Syringes | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Mixing Tips, Pre Bent Needle Tips, Irrigation Needle, Dental Needle | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | mixing tips | 2015 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor | 2026 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Dental mirror | 2025 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Matrix Band | 2023 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | intra oral tip | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Carbon Burs | 2018 |
| Resin ApplicatorKXR · Class 1 | — | Maker | micro-brushes brush applicators | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | surgical kit | 2018 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | barrier films | 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 |
|---|---|---|
| HEFEI MLUSH SANITARY PRODUCTS CO.,LTDFDA reg. 3011526299 | Hefei Anhui, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048649). 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.