BCS Bioceramic Sealer— 510(k) K262478

Substantially Equivalent

BCS Device Pte., Ltd.

FDA 510(k) clearance K262478 for BCS Bioceramic Sealer, Substantially Equivalent on 2026-10-16. Applicant: BCS Device Pte., Ltd.. Device class: 2.

Clearance details

Applicant: BCS Device Pte., Ltd.
Product code: Product code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2026-07-20
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.