510(k) clearance

ZEROS Dental Implant System

FDA 510(k) source

510(k) number

K260463

Applicant

Zeros Co., Ltd.

Decision date

Aug 19, 2026

Date received

Feb 12, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Gyeongsangnam-Do, KR