Manufacturer registered with FDA
Acumen Houseware Industry (Vietnam) Co., Ltd
Thuan An City, Vietnam. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 216 registrations outside the US
- Establishments
- 1Vietnam
Registered in 2 markets
Where regulators' registries name Acumen Houseware Industry (Vietnam) 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 | Acumen Houseware Industry (Vietnam) Co., Ltd | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | ACUMEN HOUSEWARE INDUSTRY (VIETNAM) CO., LTD | 16 | — | 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 Acumen Houseware Industry (Vietnam) 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Manual Toothbrush, VariousReach Brand | 2020 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Massaging Pick | 2020 |
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 |
|---|---|---|
| ACUMEN HOUSEWARE INDUSTRY (VIETNAM) CO., LTDFDA reg. 3010028831 | Thuan An City Binh Duong, Vietnam | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10076713). 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.