Neodent
Also known as: Neodent Grand Morse
The Brazilian implant brand wholly owned by the Straumann Group and positioned as its largest global challenger, or value, brand.
Key facts
| Manufacturer | Straumann GroupVerified spec[1] |
|---|---|
| Parent company | Straumann Holding AGVerified spec[1] |
| Country | BrazilVerified spec[2][1] |
| Headquarters | Curitiba, Brazil, where the Straumann Group also operates an implant and prosthetics manufacturing siteVerified spec[2][1] |
| Founded | Requires manual verification(Widely reported as 1993, but we have not confirmed this against a primary source) |
| Ownership | Wholly owned by the Straumann Group. Straumann acquired an initial 49% stake in 2012 and increased it to 100% in 2015Verified spec[2][1] |
| Manufacturer-described indication | Described by the group as its largest global challenger brand, intended to widen access to implant treatment at a lower price pointManufacturer-reported[1] |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance1 record
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K133592 | NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM | Neodent USA, Inc. | 2014-08-22 |
Clearance records for Neodent were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Neodent.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Straumann Group Annual Report 2025 — Straumann Holding AG, 2026. Accessed 2026-07-21.
Additional references
- [2]Straumann increases ownership of Neodent to 100% — DentistryIQ, 2015. Accessed 2026-07-21.