Dental Implant System— 510(k) K250806
Substantially EquivalentA.B. Dental Devices , Ltd.
FDA 510(k) clearance K250806 for Dental Implant System, Substantially Equivalent on 2026-06-18. Applicant: A.B. Dental Devices , Ltd.. Device class: 2.
Summary
A.B. Dental Devices' Dental Implant System is filed under DZE, root-form endosseous implants. The name is generic, and the record doesn't list implant sizes or models.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).
A.B. Dental filed from Ashdod, Israel. Review took 458 calendar days (March 17, 2025 to June 18, 2026).
Clearance details
- Applicant
- A.B. Dental Devices , Ltd.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashdod, IL
Recent devices under product code DZE
view allMore clearances from A.B. Dental Devices , Ltd.
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.