Dentalpoint (CeramTec Switzerland)
Also known as: Dentalpoint AG, CeramTec Switzerland LLC, ZERAMEX
The Swiss maker of the metal-free ZERAMEX ceramic implants, founded as Dentalpoint AG in 2005 and acquired by the CeramTec Group in 2021.
Key facts
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) clearance3 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
Clearance records for Dentalpoint (CeramTec Switzerland) 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 Dentalpoint (CeramTec Switzerland).
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]About CeramTec Switzerland LLC — CeramTec Switzerland LLC (Dentalpoint AG). Accessed 2026-07-22.
- [2]Milestones in dental implantology — Dentalpoint — CeramTec Switzerland LLC (Dentalpoint AG). Accessed 2026-07-22.