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The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.

The intended use of the AART Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.

The AART Calf Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in two styles with dimensions varying in length, width, height and initial shape. The AART Calf Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications. Short term indications for use: - Nasal splinting - Wound dressing - Management of keloid or hypertrophic scarring - Temporary use in TMJ disease - Temporary joint shims - Laboratory-uses Long term indications for use: - Nasal septal repair - Orbital floor reconstruction - Tympanic membrane repair - Dialysis shunt anchoring - Durameter repair - Staged repair of omphalocoel - Lengthening of extraocular muscles - As a protective sheathing to help facilitate neural regeneration and tendon anastomosis - As a protective sheathing to help facilitate osteogenesis - Other uses deemed appropriate by the using surgeon Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.

The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.

The intended use of the AART Silicone Carving Block is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. The rectangular blocks are designed for carving flatter devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or surgery. The contoured blocks are generally used for carving curved devices such as nasals or malars or used in body contouring to minimize muscular defects.

The AART Silicone Carving Blocks are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or rectangular shapes. They are provided in seven styles with dimensions varying in length, width, height and initial shape. Pigments may be added to the silicone to make the blocks opaque if requested by the physician. The AART Silicone Carving Block is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

The intended use of the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.

The AART Gluteal Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or round shapes. They are provided in four styles with dimensions varying in length, width, height and initial shape. The AART Gluteal Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

The AART Pectoralis Implants are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in three styles, each with a right and left mirror image. Dimensions of the implants will range from 14.4 cm to 17.6 cm in length with widths from 10.0 cm to 13.5 cm and projection (height) from 1.6 cm to 3.2 cm. The AART Pectoralis Implants are intended to be used for augmentation of the chest by placing the implant submuscular of the pectoralis muscle. They can also be used to reconstruct the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle). The surface characteristic of the implants is smooth. The AART Rectoralis. Implants will be offered non-sterile.

The intended use for the AART Chin Implant is augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision. The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.

The AART Chin Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped convex implants. They are provided in seven styles with dimensions varying in length, width, and height. The AART Chin Implants are intended to be used for augmentation and reconstruction of the chin or anterior mandibular contour. The surface characteristic of the implant is smooth. The AART Chin Implants will be offered sterile and non-sterile.

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.

The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.

The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.