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510(k) Data Aggregation

    K Number
    K163672
    Device Name
    Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
    Manufacturer
    NANOVA BIOMATERIALS, INC.
    Date Cleared
    2017-05-05

    (129 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANOVA BIOMATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair
    Device Description
    The NanovaTM Suture Anchor is comprised of two types: Screw-In and Push-In. Nanova™ Screw-In Suture Anchor is a cannulated, threaded, tapered anchor with integral eyelet for suturing soft tissue to bone. Nanova™ Push-In Suture Anchor is a cannulated anchor with integral evelet for suture soft tissue to bone. In addition the Push-In anchor can use a knotless technique by capturing suture. Suture anchors are preloaded with suture on a handled inserter with a hex driver. The device is made from a copolymer of absorbable 70-30 Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanoval Screw-In Suture Anchors are single use, prescription, long term implant, no drug.
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    K Number
    K150623
    Device Name
    Nanova Flowable Composite
    Manufacturer
    NANOVA BIOMATERIALS, INC.
    Date Cleared
    2015-06-18

    (99 days)

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

    NANOVA BIOMATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Class III and V restorations o - Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations) - Base/liner under direct restorations . - Repair of small defects in esthetic indirect restorations ● - Pit and fissure sealant ● - . Undercut blockout - Repair of resin and acrylic temporary materials o
    Device Description
    Nanova™ Flowable Dental Composite is a methacrylate based, low viscosity, visible-light activated, radiopaque, flowable composite. This device is available in syringe and ampule packaging. Nanova™ Flowable Dental Composite is available in a variety of tooth colored shades. Nanova™ Flowable Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 60% by weight. When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. Nanova™ Flowable Dental Composite formulation is based off of several FDA cleared commercially available flowable dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova™ Flowable Dental Composite using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines, including ISO 10993 Parts 3, 5, 6, 10 and 11.
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    K Number
    K140349
    Device Name
    STARBRIGHT 5% SODIUM FLUORIDE VARNISH
    Manufacturer
    NANOVA BIOMATERIALS, INC.
    Date Cleared
    2014-09-22

    (215 days)

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

    NANOVA BIOMATERIALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StarBright™ 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.
    Device Description
    StarBright™ 5% Sodium Fluoride Varnish is a rosin based 5% sodium fluoride varnish. This device is available in tray form unit doses of 0.25 and 0.40 mL. Fluoride ions within StarBright™ 5% Sodium Fluoride Varnish may react with calcium and phosphate ions in saliva to form crystals in exposed dentin tubules, such as in exposed root surfaces, leading to protection by blocking external stimuli thereby reducing hypersensitivity.
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