Data / Medical devices / Argentina / Odontit SA
Odontit SA: FDA-registered device maker in BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina, 4 510(k) clearances
Odontit SA is registered with the FDA (registration 9680963) in BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 22, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680963
- FEI number
- 3000278038
- Address
- Necochea 854, BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina, 1158
- Owner or operator
- ODONTIT SA (9012625)
- Roles
- Contract manufacturer, Foreign private label distributor, Manufacturer
- First device listed
- April 14, 2003
- Registered through
- 2026
- Brand names listed
- CITAGENIX, CevOss, Kalos Biomedical, ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE, Osseo Seal, Synergy
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Contract manufacturer, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer, Foreign private label distributor, 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 |
|---|---|---|---|---|---|---|
| May 22, 2014 | K123876 | SYNERGY | NPM | Substantially Equivalent | Odontit S.A. | accessdata.fda.gov |
| January 14, 2008 | K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | DZE | Substantially Equivalent | Odontit S.A. | accessdata.fda.gov |
| May 12, 1997 | K961631 | ODONT HEX SYSTEM | DZE | Substantially Equivalent | Odontit S.A. | accessdata.fda.gov |
| June 3, 1992 | K915375 | ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM | DZE | Substantially Equivalent | Odontit Systeme | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Implant, Endosseous, Root-Form
- All makers of Implant, Endosseous, Orthodontic
- All makers of Bone Grafting Material, Animal Source
Updated May 22, 2014. 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.