510(k) K251647
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System by
Dentsply Sirona, Inc.
— Product Code DZE
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2025
- Date Received
- May 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type