510(k) clearance

EsTemp Implant

FDA 510(k) source

510(k) number

K262983

Applicant

Spident Co., Ltd.

Decision date

Sep 25, 2026

Date received

Aug 27, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

EMA

Device type

Cement, Dental

Device class

Class II

Regulation

21 CFR 872.3275

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Incheon, KR