K253191
- 510(k) number
- K253191
- Device name
- DCMhotbond zircon
- Applicant
- Dental Creativ Management GmbH DE
- Product code
- EIH — Powder, Porcelain
- Decision date
- 2026-05-21
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253191.pdf
Official FDA record: K253191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.