510(k) clearance

BCS Bioceramic Sealer

FDA 510(k) source

510(k) number

K262478

Applicant

BCS Device Pte., Ltd.

Decision date

Oct 16, 2026

Date received

Jul 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KIF

Device type

Resin, Root Canal Filling

Device class

Class II

Regulation

21 CFR 872.3820

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Singapore, SG