Manufacturer registered with FDA
Maya Villegas S.A.S.
Medellin, Colombia. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 355 registrations outside the US
- Establishments
- 1Colombia
Registered in 3 markets
Where regulators' registries name Maya Villegas S.A.S. 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 | Maya Villegas S.A.S. | 1 device types | — | Below |
| Colombia | INVIMA | Registration holder | MAYA VILLEGAS S.A.S. | 54 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MAYA VILLEGAS S.A.S. | 1 | 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 Maya Villegas S.A.S. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | BIOGENICDURODENTMARFIL DIENTESRITE-DENT | 1998 |
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 |
|---|---|---|
| MAYA VILLEGAS S.A.S.FDA reg. 3002699241 | MEDELLIN Antioquia, Colombia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9034528). 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.