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K Number
K240304Device Name
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
Manufacturer
Enpuno Biotechnology Co., Ltd
Date Cleared
2024-05-28
(116 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Enpuno Biotechnology 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.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.
Device Description
NRSP 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. NRSP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. NRSP does not shrink during setting and demonstrates excellent physical properties. NRSP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. NRSP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. NRSP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.
Root canal filling paste is a pre mixed paste material consisting of an inorganic powder system and an organic mixed liquid. It can solidify in a humoral environment, effectively seal the root tip, and has good biocompatibility; The curing time is stable and less affected by root canal moisture and humidity; It has excellent X-ray resistance, fluidity, antibacterial properties, non staining of teeth, and no irritation.
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