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510(k) Data Aggregation

    K Number
    K212283
    Device Name
    BioRoot Flow 0.5g, BioRoot Flow 2g
    Manufacturer
    Septodont
    Date Cleared
    2021-09-16

    (57 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Septodont

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.
    Device Description
    BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe. BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is based on a tricalcium silicate reaction with in situ water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity. It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ Flow 0.5g. BioRoot™ Flow 2g is used in combination with gutta-percha points to fill the root canal.
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    K Number
    K211799
    Device Name
    Biodentine XP 500, Biodentine XP 200
    Manufacturer
    Septodont
    Date Cleared
    2021-08-10

    (61 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Septodont

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In the crown: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration; - Restoration of deep and/or large coronal carious lesions (sandwich technique); - Restoration of cervical or radicular lesions. On the pulp: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Pulp capping (direct and indirect). - Pulpotomy for diagnosed symptoms of reversible pulpitis where bleeding is controlled within 5 minutes. In the root: For permanent teeth (immature or mature): - Repair of root perforations; - Repair of furcation perforations; - Repair of perforating internal resorptions; - Repair of external resorption; - Root-end filling in endodontic surgery (retrograde filling). For immature permanent teeth - Apexification;
    Device Description
    Biodentine™ XP 500, Biodentine™ XP 200 is a bioactive dentin substitute. The product is prepared from a mixture of a Biodentine™ XP 500, Biodentine™ XP 200 powder and a liquid. The product is presented in all-in-one cartridge containing thepowder phase and the liquid phase, ready to be mixed. The medical device is presented in two presentations, the Biodentine™ XP 500 for the extraction of 500mg of finished product and the Biodentine™ XP 200 for the extraction of 200mg of finished product. The subject device is to be used with 2 accessories, the Biodentine™ Mixer and the Biodentine™ Gun.
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    K Number
    K172839
    Device Name
    ENDOSOLV
    Manufacturer
    Septodont
    Date Cleared
    2018-02-13

    (147 days)

    Product Code
    KIF, KJJ
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Septodont

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Root canal sealers solvent when canal retreatment is required.
    Device Description
    ENDOSOLV (new device, K172839/S001) is a solvent used for eugenate-type or phenolic resin-based endodontic cements in the context of endodontic retreatment. This solvent is able to soften conventional zinc oxide eugenol cements and phenolic resin type sealers in the context of endodontic retreatment. It is indicated for use as a root canal sealer solvent when canal retreatment is required. ENDOSOLV (new device, K172839/S001) composition consists of ethyl acetate, amyl acetate and thymol. Ethyl acetate and amyl acetate are the two main components of the formulation that are effective in dissolving zinc oxide-eugenol-based and resin based filling material.
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    K Number
    K140132
    Device Name
    BIODENTINE
    Manufacturer
    SEPTODONT
    Date Cleared
    2014-06-27

    (161 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biodentine™ is indicated to be used: In the crown: - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration. - Restoration of deep and/or large coronal carious lesions (sandwich technique). - Restoration of cervical radicular lesions. - Pulp capping. - Pulpotomy. In the root: - Repair of root perforations. - Repair of furcation perforations. - Repair of perforating internal resorptions. - Repair of external resorption - Apexification. - Root-end filling in endodontic surgery (retrograde filling).
    Device Description
    Not Found
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    K Number
    K110058
    Device Name
    BPA-FREE PIT AND FISSURE SEALANT
    Manufacturer
    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
    Date Cleared
    2011-03-31

    (80 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    DBA SEPTODONT AND CONFI-DENTAL PRODUC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.
    Device Description
    Not Found
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    K Number
    K101540
    Device Name
    GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
    Manufacturer
    NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
    Date Cleared
    2010-10-29

    (148 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DBA SEPTODONT AND CONFI-DENTAL PRODUC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent. N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.
    Device Description
    Not Found
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    K Number
    K093711
    Device Name
    RACEGEL
    Manufacturer
    SEPTODONT
    Date Cleared
    2010-02-17

    (78 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Racegel™ is a gel containing aluminium chloride which is intended for sulcus retraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.
    Device Description
    Racegel™ is a gel containing aluminium chloride.
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    K Number
    K092251
    Device Name
    BIODENTINE
    Manufacturer
    SEPTODONT
    Date Cleared
    2009-10-30

    (94 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When used in the crown: - Temporary enamel restorative material. - Permanent dentine restorative material. - Restoration of deep and/or large coronal carious lesions (sandwich technique). - Restoration of deep cervical and/or radicular lesions. - Pulp capping. - Pulpotomy. When used in the root: - Repair of root perforations. - Repair of furcation perforations. - Repair of perforating internal resorptions. - Repair of external resorption - Apexification. - Root-end filling in endodontic surgery (retrograde filling). Biodentine is not to be used for permanent obturation or sealing of the root canal
    Device Description
    Not Found
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    K Number
    K063634
    Device Name
    RTR SYRINGE
    Manufacturer
    SEPTODONT
    Date Cleared
    2007-05-11

    (156 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with the patient's blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.
    Device Description
    Not Found
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    K Number
    K051010
    Device Name
    SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
    Manufacturer
    SEPTODONT
    Date Cleared
    2005-05-02

    (11 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEPTODONT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up. The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up. The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
    Device Description
    Not Found
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