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510(k) Data Aggregation

    K Number
    K192381
    Device Name
    DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
    Date Cleared
    2020-02-18

    (172 days)

    Product Code
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Scientific Pharmaceuticals

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SciPharm's DFV Desensitizing Varnish is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
    Device Description
    SciPharm's DFV Desensitizing Varnish is a device that consists of a synthetic compound from a natural rosin that is intended to coat a prepared tooth cavity prior to the insertion of a restorative material by forming a film that facilitates occlusion of compromised surfaces, including open dentinal tubules. DFV Desensitizing Varnish and the predicate device consist of a viscous liquid that can be applied to the teeth using a brush or similar applicator. The purpose of the 5% sodium fluoride as the source of fluoride ions for the formation of calcium fluoride, and along with the rosin, occludes the dentin tubules. Both use denatured alcohol (ethanol) as a significant component, providing fluidity for application and to promote quick drying on the tooth surface. SciPharm's DFV Desensitizing Varnish is a topically applied, flavored (Strawberry, Bubblegum, Spearmint, Chocolate, and Marshmallow) topical varnish containing sodium fluoride on a synthetic rosin based preparation from a natural rosin. Only a professional clinician may apply DFV Desensitizing Varnish. The varnish and applicator are packaged in a thermoformed PET/PVC opaque unit dose tray, and sealed with foil.
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    K Number
    K051952
    Device Name
    EUGENONE
    Date Cleared
    2005-09-07

    (51 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Eugenone is a eugenol-free temporary cement used in the placement of temporary or temporary placement of permanent prostheses.
    Device Description
    Eugenone is a eugenol-free temporary cement.
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    K Number
    K041886
    Device Name
    PROVISO
    Date Cleared
    2004-08-04

    (23 days)

    Product Code
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Proviso™ is a self-cured material that is intended for the fabrication of temporary crowns and bridges.
    Device Description
    Not Found
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    K Number
    K013555
    Device Name
    SCI-PHARM POST SECURE
    Date Cleared
    2002-01-23

    (90 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.
    Device Description
    Not Found
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    K Number
    K001446
    Device Name
    LIGHT-CURED ORTHODONTIC BAND CEMENT
    Date Cleared
    2000-07-21

    (74 days)

    Product Code
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K993324
    Device Name
    CARBOCEM ZINC POLYCARBOXYLATE CEMENT
    Date Cleared
    1999-11-09

    (36 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For temporary or permanent cementation of crowns and bridges on non-vital and vital teeth where retention is of primary concern. Also for use as temporary filling material.
    Device Description
    Carbocem Zinc Polycarboxylate Cement
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    K Number
    K982915
    Device Name
    SCI-PHARM DFV VARNISH
    Date Cleared
    1999-02-12

    (177 days)

    Product Code
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.
    Device Description
    The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.
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    K Number
    K983305
    Device Name
    SCI-PHARM DESENSITIZING VARNISH
    Date Cleared
    1998-12-17

    (87 days)

    Product Code
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.
    Device Description
    Not Found
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    K Number
    K982913
    Device Name
    ZINFOS ZINC PHOSPHATE CEMENT
    Date Cleared
    1998-10-19

    (61 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENTIFIC PHARMACEUTICALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.
    Device Description
    ZinFos Zinc Phosphate Cement
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