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FDA 510(k)

BCS Bioceramic Sealer

K-Number: K262478 · 2026-10-16

ApplicantBCS Device Pte., Ltd.
Decision Date2026-10-16
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BCS Bioceramic Sealer is the device name listed in this FDA 510(k) record. The listed applicant is BCS Device Pte., Ltd.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K262478. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCS Bioceramic Sealer?

BCS Bioceramic Sealer is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is BCS Device Pte., Ltd.. The 510(k) number is K262478.

When did BCS Bioceramic Sealer receive FDA 510(k) clearance?

BCS Bioceramic Sealer received FDA 510(k) clearance on 2026-10-16, under 510(k) number K262478.

Who is the listed applicant for BCS Bioceramic Sealer?

The FDA 510(k) record lists BCS Device Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BCS Bioceramic Sealer?

The FDA product code for BCS Bioceramic Sealer is KIF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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