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510(k) Data Aggregation

    K Number
    K162677
    Device Name
    L- OVC
    Manufacturer
    Rhondium, Ltd
    Date Cleared
    2016-12-21

    (86 days)

    Product Code
    EIH, EBF, KLE
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rhondium, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    L-OVC is intended for restoration of permanent teeth with a single unit crown.
    Device Description
    The L-OVC is a ceramic crown, and includes an anatomic occlusal layer made of lithium disilicate, a thin priming/bonding layer that assists with bonding the occlusal layer to the sub-layer of uncured hybrid ceramic that allows for customization of the L-OVC to the specific tooth preparation. The customized L-OVC is bonded to the prepared natural tooth. The L-OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The L-OVC is selected based on tooth location and size and therefore no impressions are necessary. The L-OVC is provided in designs for the upper and lower first and second premolars and second molars, and each design is provided in five (5) sizes (extra-small (XS), small (S), medium (M), large (L), and extra-large (XL)). The L-OVC is made from lithium disilicate and high-strength ceramic composite resin. The L-OVC is provided nonsterile for singlepatient, single-use only. Accessories to the L-OVC device include the L-OVC Replica, a replica of the ceramic occlusal portion of the L-OVC. The L-OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the L-OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The L-OVC Replica is manufactured from a thermoplastic elastomer resin. L-OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size L-OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for singlepatient, single-use only. The Class I accessories are provided for informational purposes only.
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    K Number
    K143694
    Device Name
    Rhondium One-Visit-Crown(OVC)
    Manufacturer
    Rhondium, Ltd.
    Date Cleared
    2015-05-15

    (142 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rhondium, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.
    Device Description
    Rhondium One-Visit-Crown (OVC) is a hybrid ceramic crown consisting of a fully-cured anatomical occlusal layer and an uncured sub-layer that allows customization of the OVC to the tooth preparation. When finished, the customized OVC is bonded to a prepared natural tooth. The OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The OVC is selected based on tooth location and size and therefore no impressions are necessary. The OVC is provided in designs for the upper and lower first and second premolars and the first and second molars, and each design is provided in six (6) sizes (extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL)). The OVC is made from a ceramic tooth shade resin material, and is provided nonsterile for single use only. Accessories to the OVC Device include the OVC Replica, an exact replica of the cured (occlusal layer) portion of the OVC. The OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The OVC Replica is manufactured from vinyl polysiloxane impression material. OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for single use only.
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