Osstem Implant
Dental implants, dental equipment and digital dentistry products.
Osstem Implant manufactures dental implants, dental equipment and digital dentistry products from its Seoul operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Seoul, South Korea
- Founded
- 1997
- Website
- osstem.com
- Categories
- Medical & Healthcare Supplies, Dental Supplies & Equipment
- Markets
- South Korea, United States, Germany, China
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- places-goods-on-market (green), checked 2021-03-30 Ministry of Public Health, Lebanon - authorized implantable medical devices
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- fda-registered (green), checked 2026-08-09 FDA
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
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)