Osstem Implant Denmark
Dental implant systems and surgical equipment for Scandinavia.
Osstem Implant Denmark is the Nordic distribution arm of Osstem Implant (South Korea), supplying dental implants, guided surgery systems and digital dentistry solutions to Scandinavian dental clinics and lab suppliers.
- Type
- brand seeking distribution
- Location
- Aarhus, Denmark
- Founded
- 2000
- Website
- osstem.dk
- Categories
- Medical & Healthcare Supplies, Dental Supplies & Equipment
- Markets
- Denmark, Germany, Sweden, Norway
Claimed certifications
- CE Marking EU NANDO (notified bodies)
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)