Cleared Traditional

K252031 - Adin Long Dental Implant System (FDA 510(k) Clearance)

Mar 2026
Decision
266d
Days
Class 2
Risk

K252031 is an FDA 510(k) clearance for the Adin Long Dental Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).

Submitted by Adin Dental Implant Systems , Ltd. (Afula, IL). The FDA issued a Cleared decision on March 23, 2026, 266 days after receiving the submission on June 30, 2025.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K252031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2025
Decision Date March 23, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE - Implant, Endosseous, Root-form
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.3640

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