Manufacturer registered with FDA
Masterdent Ltda.
ENVIGADO-ANTIOQUIA, Colombia. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 12000–2000
- Markets registered in
- 618 registrations outside the US
- Establishments
- 1Colombia
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Masterdent Ltda. 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 | Masterdent Ltda. | 1 clearances | 2000–2000 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | MASTERDENT LTDA | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MASTERDENT S.A.S.MASTERDENT LTDA | 4 | 2011–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | MasterDent Ltda.MASTERDENT LTDA. · Masterdent LTDA | 4 | 2000–2016 | Pure Global AI |
| Colombia | INVIMA | Registration holder | MASTERDENT S.A.S. | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MASTERDENT LTDA | 1 | 2018–2018 | 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 Masterdent Ltda. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | DAVINCIRAFAELRESISTALSTARDENTSTARPLUSSTARVIT | 2008 |
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 |
|---|---|---|
| MASTERDENT, LTDAFDA reg. 9615141 | Medellin Antioquia, Colombia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9038858). 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.