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FDA 510(k)

Bioceramic Root Repair Material (C-Root BP)

K-Number: K240365 · 2024-05-10

ApplicantBeijing C-Root Dental Medical Devices Co., Ltd.
Decision Date2024-05-10
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bioceramic Root Repair Material (C-Root BP) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing C-Root Dental Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240365. 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 Bioceramic Root Repair Material (C-Root BP)?

Bioceramic Root Repair Material (C-Root BP) is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Beijing C-Root Dental Medical Devices Co., Ltd.. The 510(k) number is K240365.

When did Bioceramic Root Repair Material (C-Root BP) receive FDA 510(k) clearance?

Bioceramic Root Repair Material (C-Root BP) received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240365.

Who is the listed applicant for Bioceramic Root Repair Material (C-Root BP)?

The FDA 510(k) record lists Beijing C-Root Dental Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioceramic Root Repair Material (C-Root BP)?

The FDA product code for Bioceramic Root Repair Material (C-Root BP) is KIF.

Other records listing Beijing C-Root Dental Medical Devices Co., Ltd. as applicant

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.

K212983Injectable Root Canal Bioceramic Sealer

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.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

Official Source

View on FDA Database →

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

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