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510(k) Data Aggregation

    K Number
    K201222
    Device Name
    Bio-C Repair Ion+
    Manufacturer
    Angelus Industria de Produtos Odontologicos S/A
    Date Cleared
    2021-02-11

    (281 days)

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

    Angelus Industria de Produtos Odontologicos S/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - · Furcation or root perforation treatment via canal; - · Furcation or root perforation treatment via surgical; - · Internal reabsorption treatment via canal or surgical; - · External reabsorption treatment; - · Retrofilling in parendodontic surgery; - · Direct and indirect pulp capping; · Apexification; - · Apexogenesis and Pulpotomy.
    Device Description
    BIO-C REPAIR ION+ is a bioceramic reparative material ready-to-use suitable for furcation or root perforation treatment via canal, furcation treatment via surgical, internal reabsorption treatment via canal or surgical, external reatment, retrofilling in parendodontic surgery, direct and indirect pulp capping, apexification, apexogenesis and pulpotomy. The product is a single paste provided in a syringe with blunt tips to be applied into the root canal system. BIO-C REPAIR ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root repair materials.
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    K Number
    K190537
    Device Name
    BIO-C Sealer Ion+
    Manufacturer
    Angelus Industria de Produtos Odontologicos S/A
    Date Cleared
    2019-12-12

    (283 days)

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

    Angelus Industria de Produtos Odontologicos S/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Sealing the root canal of permanent teeth; 2. Internal reabsorption treatment.
    Device Description
    BIO-C SEALER ION* is a ready-to-use injectable bioceramic root canal sealer, developed for sealing the root canals and for the treatment of internal reabsorption. The product is a single paste provided in a syringe with disposable intracanal tips to be applied directly into the root canal system. BIO-C SEALER ION* is an insoluble and alkaline material, which requires the presence of water to set and harden. The product presents suitable radiopacity, demonstrating adequate physical properties inherent to root canal sealer materials.
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    K Number
    K180199
    Device Name
    BIO-C TEMP
    Manufacturer
    Angelus Industria de Produtos Odontologicos S/A
    Date Cleared
    2019-01-04

    (345 days)

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

    Angelus Industria de Produtos Odontologicos S/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Intracanal dressing for endodontic treatment of pulp necrosis and retreatments. - Intracanal dressing in cases of perforations, external and internal resorptions, prior to the use of MTA ANGELUS OR MTA REPAIR HP. - For the treatment of incomplete root formation (rizogenesis): Apexification - the formation of the apex in cases of pulp necrosis; Apexigenesis - the formation of the apex in cases of vital pulp.
    Device Description
    Not Found
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    K Number
    K180185
    Device Name
    BIO-C REPAIR
    Manufacturer
    Angelus Industria de Produtos Odontologicos S/A
    Date Cleared
    2018-08-31

    (220 days)

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

    Angelus Industria de Produtos Odontologicos S/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reparative cement for endodontic complications. 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
    BIO-C REPAIR is a ready-to-use bioceramic MTA-based paste developed for permanent root canal repair and surgical applications. The product is a single paste provided in a syringe with disposable tips to be applied to the affected area of the root canal system. BIO-C REPAIR is an insoluble and radiopaque material which requires the presence of water to set and harden.
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    K Number
    K172701
    Device Name
    BIO-C SEALER
    Manufacturer
    Angelus Industria de Produtos Odontologicos S/A
    Date Cleared
    2018-01-04

    (119 days)

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

    Angelus Industria de Produtos Odontologicos S/A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Sealing the root canal of permanent teeth; - Internal reabsorption treatment;
    Device Description
    BIO-C SEALER is a ready-to-use injectable endodontic bioceramic sealer, suitable for obturation of root canals.
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