K242521
- 510(k) number
- K242521
- Device name
- Estar-ZE
- Applicant
- Osstem Implant Co., Ltd. KR
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2024-11-20
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242521.pdf
Official FDA record: K242521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.