Data / Medical devices / Colombia / Masterdent, Ltda
Masterdent, Ltda: FDA-registered device maker in Medellin Antioquia, Colombia, 1 510(k) clearance
Masterdent, Ltda is registered with the FDA (registration 9615141) in Medellin Antioquia, Colombia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 7, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615141
- FEI number
- 3002926915
- Address
- Carrera 42 # 39 sur - 90, Envigado-Colombia, Medellin Antioquia, Colombia, 055421
- Owner or operator
- MASTERDENT LTDA (9038858)
- Roles
- Manufacturer
- First device listed
- January 17, 2008
- Registered through
- 2026
- Brand names listed
- DAVINCI, RAFAEL, RESISTAL, STARDENT, STARPLUS, STARVIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 7, 2000 | K992854 | ARTIFICIAL TEETH (ACRYLIC TEETH) | ELM | Substantially Equivalent | Masterdent Ltda. | accessdata.fda.gov |
Compare with other makers
Updated February 7, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.