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K Number
K242934Device Name
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
Manufacturer
Longly Biotechnology (Wuhan) Co., Ltd.
Date Cleared
2024-12-12
(78 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Longly Biotechnology (Wuhan) Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
Device Description
i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.
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K Number
K241977Device Name
Injectable Root Canal Bioceramic Sealer (i-MTA SP)
Manufacturer
Longly Biotechnology (wuhan) CO., LTD
Date Cleared
2024-10-03
(90 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Longly Biotechnology (wuhan) CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Permanent obturation of the root canal following vital pulp-extirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.
Device Description
i-MTA 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. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
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