510(k) clearance

MultiNeO Dental Implant System

FDA 510(k) source

510(k) number

K261295

Applicant

Alpha Bio Tec , Ltd.

Decision date

Oct 22, 2026

Date received

Apr 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DZE

Device type

Implant, Endosseous, Root-Form

Device class

Class II

Regulation

21 CFR 872.3640

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Modi'In, IL