Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Osstem ImplantLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Osstem Co., Ltd. with 1 510(k) clearance. The most recent is a 510(k) clearance dated Sep 1, 2005: AVANA DENTAL IMPLANT SYSTEM.
| Date | Record | Source |
|---|---|---|
| Sep 1, 2005 | AVANA DENTAL IMPLANT SYSTEMK051576 ยท DZE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
