K243834
- 510(k) number
- K243834
- Device name
- NobelZygoma TiUltra Implant system
- Applicant
- Nobel Biocare AB SE
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-08-25
- Date received
- 2024-12-13
- 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: K243834.pdf
Official FDA record: K243834
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.