Adin Long Dental Implant System— 510(k) K252031
Substantially EquivalentAdin Dental Implant Systems , Ltd.
FDA 510(k) clearance K252031 for Adin Long Dental Implant System, Substantially Equivalent on 2026-03-23. Applicant: Adin Dental Implant Systems , Ltd.. Device class: 2.
Summary
Adin Dental Implant Systems' Adin Long Dental Implant System is filed under DZE, root-form endosseous implants. The record doesn't list implant lengths or diameters.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
Adin Dental Implant Systems filed from Afula, Israel. The decision came 266 calendar days after receipt (June 30, 2025 to March 23, 2026).
Clearance details
- Applicant
- Adin Dental Implant Systems , 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
- Afula, IL
Recent devices under product code DZE
view allMore clearances from Adin Dental Implant Systems , 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.