Manufacturer registered with FDA
DEGASA S.A. de C.V.
Morelos, Mexico. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 4451 registrations outside the US
- Establishments
- 1Mexico
Registered in 4 markets
Where regulators' registries name DEGASA S.A. de C.V. 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 | DEGASA S.A. de C.V. | 1 device types | — | Below |
| Mexico | COFEPRIS | Registration holder | Degasa, S.A. de C.V.DEGASA, S.A. DE C.V. · DEGASA S.A. DE C.V. · +2 | 415 | 1986–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DEGASA S.A. DE C.V.DEGASA S.A DE CV · DEGASA, S.A. DE C.V. | 33 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DEGASA S.A. DE C.V.DEGASA S.A. de C.V. | 3 | — | 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 DEGASA S.A. de C.V. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | PROTEC COTTON BALLSPROTEC COTTON, ROLL | 1994 |
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 |
|---|---|---|
| DEGASA, S.A. DE C.V.FDA reg. 8030654 | Jiutepec Morelos, Mexico | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8030654). 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.