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The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136).

Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).

The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.

Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

This submission extends the indication for the Nobel Biocare Endosseous Implants to use in maxillofacial reconstructive surgery. There is no change to existing product marketed for dental applications.

For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

The Monarch Nasal Implant is a Class II Device. The Monarch Nasal Implant is available in 48mm and 44mm lengths and is 1cm wide at the ends. The thickness is 1.5mm to 2mm around the edges. The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous, Intercartilaginous Approach and The Open Technique. The Monarch Nasal Implant is comprised of ePTFE and Medical Grade Titanium Alloys.

Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.

The intended use of the AART Nasal Implant is for cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal Implants will be offered sterile and non-sterile.

Seare Biomedical Nasal Implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.