K260370
- 510(k) number
- K260370
- Device name
- Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- Applicant
- Bloomden Bioceramics (HuNan) Co., Ltd. CN
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2026-03-30
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260370.pdf
Official FDA record: K260370
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.