Manufacturer registered with FDA
Odontit S.A.
BUENOS AIRES, Argentina. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 9
- 510(k) clearances
- 31997–2014
- Markets registered in
- 533 registrations outside the US
- Establishments
- 1Argentina
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name Odontit S.A. 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 | Odontit S.A. | 3 clearances | 1997–2014 | Below |
| Argentina | ANMAT | Registration holder | ODONTIT S.A. | 29 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ODONTIT SA | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | ODONTIT S.A. | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | ODONTIT S.A. | 1 | — | 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 Odontit S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Kalos BiomedicalODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE | 2010 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | CevOssCITAGENIXKalos BiomedicalOsseo SealSynergy | 2014 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Kalos BiomedicalODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Odontit S.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 May 2014 | K123876 | SYNERGY | NPM Animal Source Bone Grafting Material |
| 14 Jan 2008 | K072917 | JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 12 May 1997 | K961631 | ODONT HEX SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: alfa gate - mazen ltd. (1).
Also lists devices cleared under other names
Odontit S.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Odontit Systeme (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Jun 1992 | K915375 | ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM | Odontit Systeme | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ODONTIT SAFDA reg. 9680963 | BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina | Contract manufacturer, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012625). 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.