Manufacturer registered with FDA
Premium Plus (Dongguan) Limited
Dongguan, China. Lists 22 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 22
- Brands and models
- 34
- 510(k) clearances
- 22025–2025
- Markets registered in
- 5105 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Premium Plus (Dongguan) Limited 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 | Premium Plus (Dongguan) Limited | 2 clearances | 2025–2025 | Below |
| United Kingdom | MHRA | Manufacturer | Premium Plus (Dongguan) Limited | 39 | — | Pure Global AI |
| Australia | TGA | Manufacturer | PREMIUM PLUS (DONGGUAN) LTD | 33 | 2025–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Premium Plus (Dongguan) Limited | 32 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PREMIUM PLUS (DONGGUAN) LIMITED | 1 | 2012–2012 | 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 Premium Plus (Dongguan) Limited 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 ejectors | 2024 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Applicator tipsFlowable composite and etching gel tips | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Composite syringe gun, composite syringe tips | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth mirrors, Intraoral Mirrors | 2024 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Activator, for polymerization, Dental Curing Light | 2025 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | air-water syringe tipsgreenline syringe tips | 2025 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | interdental brush, brush | 2024 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Disposable Prophy Angles | 2025 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Disposable peel-n-stick sensor holdersX-Ray Bite Cushions, Bite Wing LoopsX-Ray film holder, film clips | 2024 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Disposable Prophy BrushesDisposable Prophy Cups | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression trays, 3-IN-1 Trays | 2024 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | HVE Suction TubesOral evacuators | 2024 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Impression syringes,curved tip syringeIntraoral Syringe Tips | 2024 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek retractor, mouth props, intraoral lippers | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Hand instrumentsPlastic wedges | 2024 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | Rubber dam frame | 2024 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Dental bibsTray papers | 2024 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Fluoride trays | 2024 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Brush applicator, brush tips, applicatorsMicro Applicators | 2025 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue cleaners | 2025 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dental accessoriesorganisers, dispensers, holders, retainers, denture boxestooth fracture detector,spatula, napkin holders, instrument rings, mask extenders | 2024 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Headrest Covers | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Premium Plus (Dongguan) Limited as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PREMIUM PLUS (DONGGUAN) LIMITEDFDA reg. 3027234828 | Dongguan Guangdong, China | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092177). 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.