LogoFDA 510(k) Search
Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K112397
    Device Name
    ORTHO-JET CRYSTAL
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2011-11-04

    (77 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin is intended for the fabrication of methacrylate-based orthodontic appliances and is intended for use when aesthetically clear acrylic appliances, such as orthodontic retainers, are desired.
    Device Description
    Lang Dental Ortho-Jet Crystal, Clear Acrylic Resin
    Ask a Question
    K Number
    K100653
    Device Name
    JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2010-10-08

    (214 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LANG DENTAL Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based acrylic appliances and used wherever a radiopague acrylic dental device is useful in establishing an anatomical location or site, such as a provisional implant stent
    Device Description
    Lang Dental Jet XR Radiopaque Acrylic Resin is a high quality self curing 2-part system. The system is formed by a powder polymer and liquid monomer. The combination of powder polymer and liquid monomer is converted into a hard methacrylate finished product. Lang Dental Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based actylic appliances that require radiopacity.
    Ask a Question
    K Number
    K083195
    Device Name
    MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2009-06-05

    (219 days)

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

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.
    Device Description
    Not Found
    Ask a Question
    K Number
    K081981
    Device Name
    LANG DENTAL ACRYLIC PRIMER
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2008-11-17

    (129 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LANG DENTAL Acrylic Primer is intended for use as an acrylic bonding agent when adding new acrylic to existing denture base acrylic.
    Device Description
    Not Found
    Ask a Question
    K Number
    K081514
    Device Name
    TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2008-09-22

    (115 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LANG DENTAL TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN is intended for the fabrication of denture relines.
    Device Description
    Not Found
    Ask a Question
    K Number
    K081705
    Device Name
    LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2008-09-17

    (92 days)

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

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LANG DENTAL RESINCAP PATTERN AND COPING ACR YLIC RESIN is intended for the fabrication of patterns and copings.
    Device Description
    Not Found
    Ask a Question
    K Number
    K072580
    Device Name
    JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2007-11-05

    (53 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K972553
    Device Name
    LANG DENTAL RESIN A97 FIBRED PINK
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    1997-11-13

    (128 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANG DENTAL MFG. CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin developed for the fabrication of removable partial dentures and for reconditioning dentures for processes such as repairs, relines and modulation of margins and extension.
    Device Description
    Lang Dental Resin A97 Fibred Pink is a self-curing powder/liquid resin.
    Ask a Question

    Page 1 of 1