Manufacturer registered with FDA
Vago International Manufacturing SA DE CV
Monterrey, Mexico. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Mexico
Registered in 2 markets
Where regulators' registries name Vago International Manufacturing SA DE CV 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 | Vago International Manufacturing SA DE CV | 5 device types | — | Below |
| Mexico | COFEPRIS | Registration holder | Vago International Manufacturing, S.A. de C.V. | 2 | 2017–2017 | 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 Vago International Manufacturing SA DE CV currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Gishy Goo | 2024 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Umbrella Cheek Retractor | 2024 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | OMNI-MATRIX ORIGINAL WINGED; ORIGNAL WINGLESS; SECTIONAL; WINGES; WINGLESS | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss, Dental | 2023 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Lister | NUSMILE | 2017 |
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 |
|---|---|---|
| VAGO INTERNATIONAL MANUFACTURING SA DE CVFDA reg. 3001655856 | Monterrey Nuevo Leon, Mexico | Contract manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043331). 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.