Manufacturer registered with FDA
Isa Mould Engineering Limted
Dongguan, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Isa Mould Engineering Limted currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | dental crown spreader | 2026 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | — | 2022 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | rota-pointtoothpick | 2026 |
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 |
|---|---|---|
| ISA MOULD ENGINEERING LIMTEDFDA reg. 3016427447 | Dongguan Guangdong, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084901). 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.