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510(k) Data Aggregation
K Number
K250710Device Name
Injectable Root Canal Bioceramic Sealer (nRoot SP)
Manufacturer
Enpuno Co., Ltd
Date Cleared
2025-06-11
(93 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
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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 (nRoot SP) is suitable for use in the single cone and lateral condensation technique.
Device Description
Injectable Root Canal Bioceramic Sealer (nRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. nRoot SP is an insoluble, radiopaque on a calcium silicate composition, which requires the presence of water to set and harden. nRoot SP does not shrink during setting and demonstrates excellent physical properties.
nRoot SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. nRoot SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. Injectable Root Canal Bioceramic Sealer (nRoot SP) is available in five preloaded syringe mode that provide different in specification in 5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.
The performance of the Injectable Root Canal Bioceramic Sealer (nRoot SP) conforms to ISO 6876:2012 Dentistry - Root canal sealing materials.
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K Number
K243353Device Name
One-Fil Putty
Manufacturer
MEDICLUS CO., LTD.
Date Cleared
2025-03-14
(136 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- 1. Furcation or root perforation treatment via canal
- 2. Furcation or root perforation treatment via surgical
- 3. Internal reabsorption treatment via canal or surgical
- 4. External reabsorption treatment
- 5. Retrofilling in parendodontic surgery
- 6. Direct and indirect pulp capping
- 7. Apexification
- 8. Apexogenesis and Pulpotomy
Device Description
One-Fil putty is a permanent root canal filling repair material with tricalcium aluminate compound that are premixed and designed to be convenient for use. It is hardened by moisture, has characteristics of adhesion and workability. The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.
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K Number
K243546Device Name
AH Plus Endodontic Sealer
Manufacturer
Dentsply Sirona Inc.
Date Cleared
2025-02-13
(90 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent obturation of root canals of the secondary dentition in combination with root canal points.
Device Description
AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.
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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?
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Matched: '872.3820'
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
K242702Device Name
VioSeal
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2024-11-07
(59 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent obturation of root canals of the permanent teeth in combination with root canal points
Device Description
VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.
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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?
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Matched: '872.3820'
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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K Number
K241457Device Name
Vista BC Putty
Manufacturer
Inter-Med, Inc.
Date Cleared
2024-08-28
(97 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
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Matched: '872.3820'
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
Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.
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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?
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Matched: '872.3820'
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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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?
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Matched: '872.3820'
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
K232182Device Name
One-Fil
Manufacturer
Mediclus Co., Ltd.
Date Cleared
2024-01-26
(186 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Search-Everything :
Matched: '872.3820'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Permanent sealing of root canal
Device Description
One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
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