K250806
- 510(k) number
- K250806
- Device name
- Dental Implant System
- Applicant
- A.B. Dental Devices , Ltd. IL
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2026-06-18
- Date received
- 2025-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250806
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.