Cleared Traditional

K262478 - BCS Bioceramic Sealer

K262478 is an FDA 510(k) clearance for BCS Bioceramic Sealer, manufactured by BCS Device Pte., Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K262478 · BCS Device Pte., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
88d
Days
Class 2
Risk

K262478 is an FDA 510(k) clearance for the BCS Bioceramic Sealer. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by BCS Device Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on October 16, 2026 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262478

510(k) Number K262478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2026
Decision Date October 16, 2026
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 146
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K262478.
Vioseal X
K262050 · Spident Co., Ltd. · Sep 2026
NeoPEX™ Pre-Mixed Obturation Paste
K253909 · NuSmile, Ltd. · Sep 2026
Calcium Hydroxide Temporary Filling Material (KP-Cal)
K261514 · Guilin Kevin Peter Technology Co., Ltd. · Aug 2026
Any-Paste
K253167 · Mediclus Co., Ltd. · Jan 2026
ZenSeal Pro
K252890 · Kerr Corporation · Jan 2026
Root canal repair materials (nRoot BP)
K251465 · Enpuno Biotechnology Co., Ltd. · Sep 2025
K262478 · BCS Bioceramic Sealer
Download PDF FDA Summary BCS Device Pte., Ltd.