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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 a medical device manufactured by Beijing C-Root Dental Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under approval 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. It is manufactured by Beijing C-Root Dental Medical Devices Co., Ltd.. The 510(k) number is K240365.

When was Bioceramic Root Repair Material (C-Root BP) approved by the FDA?

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

What company makes Bioceramic Root Repair Material (C-Root BP)?

Bioceramic Root Repair Material (C-Root BP) is manufactured by Beijing C-Root Dental Medical Devices Co., Ltd..

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.

Related Clinical Trials

NCT06899711 External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients RECRUITING NCT06710795 AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40876809 Applications of Tissue-Inducing Biomaterials in Nonosseous Tissues: Evidence Map of Animal Studies. Tissue engineering. Part A (2026)

Other Devices by Beijing C-Root Dental Medical Devices Co., Ltd.

K212983Injectable Root Canal Bioceramic Sealer

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom 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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