510(k) clearance

Core·it Dual

FDA 510(k) source

510(k) number

K262982

Applicant

Spident Co., Ltd.

Decision date

Sep 21, 2026

Date received

Aug 27, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

EBF

Device type

Material, Tooth Shade, Resin

Device class

Class II

Regulation

21 CFR 872.3690

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Incheon, KR