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510(k) Data Aggregation
K Number
K240365Device Name
Bioceramic Root Repair Material (C-Root BP)
Manufacturer
Beijing C-Root Dental Medical Devices Co., Ltd.
Date Cleared
2024-05-10
(94 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Beijing C-Root Dental Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
Device Description
C-Root BP Bioceramic Root Repair Material (C-Root BP) is a convenient ready-to-use premixed bioceramic paste developed for permanent root canal repair and surgical applications. C-Root BP is an insoluble, radiopaque and aluminum-free material based on a strontium silicate composition, which requires the presence of water to set and harden. C-Root BP does not shrink during setting and demonstrates excellent physical properties. C-Root BP is packaged in a Preloaded syringe.
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K Number
K212983Device Name
Injectable Root Canal Bioceramic Sealer
Manufacturer
Beijing C-Root Dental Medical Devices Co., LTD.
Date Cleared
2021-12-08
(82 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Beijing C-Root Dental Medical Devices Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
* Permanent obturation of the root canal following vital pulpextirpation.
* Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
C-Root SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
Device Description
C-Root SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. C-Root SP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. C-Root SP does not shrink during setting and demonstrates excellent physical properties. C-Root SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. C-Root SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
C-Root SP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in2g; 1g; 0.5g. The only difference between the types are the net weight.
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