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Nanova 2 Step Etch and Rinse Dental Adhesive is indicated for use in: - All direct restorations - All indirect restorations - Intra-oral repairs - Desensitizing/sealing of tooth structure - Priming of enamel for orthodontic use

Nanova™ 2 Step Etch and Rinse Dental Adhesive is a methacrylate based, visible-light activated, dental adhesive, the same as the predicate. This device is available in bottle or unit dose packaging, the same as the predicate. Nanova™ 2 Step Etch and Rinse Dental Adhesive contains ethanol, methacrylate resins, photoinitiator, and inorganic filler material the same as the predicate. When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard sealant that is bonded to the prepared tooth structure.

Nanova Sealant is indicated for use as a pit and fissure sealant

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Nanova™ Interference Screw is indicated for the fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws are also indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Nanova™ Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer of absorbable Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanova™ Interference Screws are single use, prescription, long term implant, no drug.

Vas-Q-Clip™ ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Nanova Biomaterials Inc.'s Vas-Q-Clip™ causes hemostasis through vessel ligation. The technological characteristics are the same as or equivalent to the predicate device. The non-absorbable polyacetal material used in the clips is the same as the predicate device and the clips are manufactured in a similar manner. The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding and is sold sterile. The method of sterilization is EtO with a SAL of 10-6. The blisters are fitted into a carton in which the clips are sold. The Vas-O-Clip™ outer structure including legs, bosses, hook and latch mechanism, and hinge are the same as the Hem-o-lok® design (Shape and dimensions are the same for the corresponding sizes). The only difference is the inner closure feature designated as "teeth". Vas-Q-Clip™ triangular protrusions (teeth) are perpendicular to the vessel whereas the Hem-O-Lok teeth are parallel.

Nanova Universal Dental Composite is indicated for use in: - · Direct anterior and posterior restorations (including occlusal surfaces) - Core Build-ups - · Splinting - · Indirect restorations including inlays, onlays and veneers

Nanova™ Universal Dental Composite is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova™ Universal Dental Composite is available in a variety of tooth colored shades. Nanova"™ Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% 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™ Universal Dental Composite formulation is based off of several FDA approved commercially available universal 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™ Universal Dental Composite using standard risk assessment techniques and consideration of FDA & International Standards, including ISO 10993 Parts 5 and 10.