Not currently registered with FDA under this name
Neodent USA, Inc.
Andover, MA, United States. Named as applicant on 1 dental 510(k) clearance between 2014 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12014–2014
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Neodent USA, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Aug 2014 | K133592 | NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Institut Straumann AG (1).
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.