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    K Number
    K230270
    Device Name
    3M™ VitCal Liner/Base
    Manufacturer
    3M ESPE Dental Products
    Date Cleared
    2023-02-06

    (6 days)

    Product Code
    EJK
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.
    Device Description
    3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.
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    K Number
    K212475
    Device Name
    Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2022-05-13

    (280 days)

    Product Code
    EJK
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apacal ART and is suitable for several indications including: - · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. - · Indirect pulp capping or management of deep caries lesions, or - · Direct pulp capping CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled. Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including; - · Indirect pulp capping or management of deep caries lesions, or · Direct pulp capping CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
    Device Description
    Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips. CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips. Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips. CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.
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    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
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    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
    K201799
    Device Name
    CleaniCal
    Manufacturer
    Maruchi
    Date Cleared
    2021-02-12

    (227 days)

    Product Code
    EJK, KIF
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CleaniCal is a Calcium Hydroxide paste that has a creamy consistency and is suitable for several indications including: * Temporary disinfectant dressings in the obturation of root canals; * Indirect pulp capping or management of deep caries lesions; or * Direct pulp capping.
    Device Description
    CleaniCal is a type of pre-filled syringe to Calcium Hydroxide Paste with a pH 12.3.
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    K Number
    K202413
    Device Name
    LC ResinCal PC
    Manufacturer
    S&C Polymer Silicon- und Composite Spezialitaten GmbH
    Date Cleared
    2020-11-20

    (88 days)

    Product Code
    EJK
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Pulp capping agent 2. Liner
    Device Description
    Resin modified light cure pulp capping material / liner (indications from labeling).
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    K Number
    K190091
    Device Name
    Diapaste
    Manufacturer
    Diadent Group International
    Date Cleared
    2020-03-27

    (434 days)

    Product Code
    KIF
    Regulation Number
    872.3820
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aqueous ointment material that temporarily fills the root canal for the following indications: - Apexification - Temporary root filling - Root canal filling for primary teeth - Vital pulpotomy - Temporary pulp capping
    Device Description
    Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
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    K Number
    K191103
    Device Name
    Parkell Desensitizer Gel
    Manufacturer
    Parkell, Inc.
    Date Cleared
    2019-11-22

    (211 days)

    Product Code
    EJK, LBH
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Parkell® Desensitizer Gel is indicated for reduction of tooth hypersensitivity by the following treatments: - · treatment of dentin exposed by toothbrush abrasion, periodontal disease, and/or acid erosion; - · treatment of dentin after mechanical tooth cleaning, scaling, and/or root planning; - · treatment of tooth hypersensitivity associated with bleaching: and - · treatment of prepared dentin for fillings and/or prosthetic restorations.
    Device Description
    Parkell® Desensitizer Gel alleviates dental hypersensitivity at treatment sites. It is a gel which requires no mixing prior to use and which is applied to treatment sites using a standard applicator brush. Parkell® Desensitizer releases calcium and phosphate ions at the treatment site and stimulates hydroxyapatite formation on the surface of treated dentin and in dentinal tubules. In this manner, the Device hardens following application and forms a layer of mineral hydroxyapatite as well as hydroxyapatite plugs which occlude dentinal tubules, which results in the treatment of dental hypersensitivity. Parkell® Desensitizer Gel is packaged in any standard single-chamber syringe. The syringe is accompanied by standard snap-in tips and standard applicator brushes.
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    K Number
    K180344
    Device Name
    TheraCal DC
    Manufacturer
    Bisco, Inc.
    Date Cleared
    2018-04-05

    (56 days)

    Product Code
    EJK, CLA
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TheraCal DC is indicated for use for: 1. Pulpotomy 2. Temporary Filling Material 3. Repair of Root Perforations 4. Repair of Furcation Perforations 5. Repair of Perforating Internal and External Resorptions 6. Root-End Filling in Endodontic Surgery 7. Pulp Exposures (Direct Pulp Capping) 8. Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
    Device Description
    TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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    K Number
    K143292
    Device Name
    TheraCal DC
    Manufacturer
    Bisco Inc
    Date Cleared
    2015-08-04

    (260 days)

    Product Code
    EJK, CLA
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TheraCal DC is indicated for use for: - 1. Pulpotomy - 2. Temporary filling material - 3. Repair of root perforations - Repair of furcation perforations 4. - 5. Repair of perforating internal and external resorptions - 6. Root-end filling in endodontic surgery - 7. Pulp exposures (direct pulp capping) - 8. Protective liner (Indirect Pulp Capping) and Base for use under a variety of substrates
    Device Description
    TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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    K Number
    K150559
    Device Name
    Life Fast Set, Life Regular Set
    Manufacturer
    SYBRON DENTAL SPECIALTIES
    Date Cleared
    2015-06-19

    (105 days)

    Product Code
    EJK
    Regulation Number
    872.3250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
    Device Description
    Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set.
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