Not currently registered with FDA under this name
Bonafix Surgical and Dental Implants
Delray Beach, FL, United States. Named as applicant on 3 dental 510(k) clearances between 2012 and 2017. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32012–2017
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Bonafix Surgical and Dental Implants as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Bonafix Surgical and Dental Implants | 3 clearances | 2012–2017 | Below |
| Colombia | INVIMA | Manufacturer | BONAFIX SURGICAL & DENTAL IMPLANTS | 2 | — | 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
510(k) clearances
Clearances on which FDA names Bonafix Surgical and Dental Implants as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Jul 2017 | K162853 | Bonafix TWO - Dental Implant System | DZE Root-Form Endosseous Implant |
| 28 Nov 2012 | K122052 | MINIFIX BALL MINIFIX ONE | DZE Root-Form Endosseous Implant |
| 3 Oct 2012 | K113650 | ORTHOFIX SCREW | OAT Orthodontic Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Zentek Medical LLC (3).
Sources
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 of the most recent filing, which can be a US agent.