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510(k) Data Aggregation

    K Number
    K151748
    Device Name
    Clean & More
    Manufacturer
    3M DEUTSCHLAND GMBH
    Date Cleared
    2016-03-11

    (256 days)

    Product Code
    PIP, LBH
    Regulation Number
    872.6080
    Why did this record match?
    Product Code :

    PIP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains · Professional cleaning of teeth including patients with dentin hypersensitivity · Treatment of dentin hypersensitivity by blockage of the dentin tubules · Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants · For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth · For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
    Device Description
    Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices. Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.
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    K Number
    K140684
    Device Name
    CLINPRO PROPHY POWDER
    Manufacturer
    3M DEUTSCHLAND GMBH
    Date Cleared
    2014-10-24

    (220 days)

    Product Code
    PIP
    Regulation Number
    872.6080
    Why did this record match?
    Product Code :

    PIP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants - For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only - For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only Calculi and tartar cannot be removed with Clinpro Prophy Powder.
    Device Description
    Clinpro TM Prophy Powder is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.
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