K251647
- 510(k) number
- K251647
- Device name
- MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-08-21
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251647.pdf
Official FDA record: K251647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.