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Each Pillar Chin Implant is indicated for the augmentation or reconstruction of facial chin deformities, congenital or acquired by trauma or disease.

The Pillar Chin Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.

Each Pillar Malar Implant is indicated for the augmentation or reconstruction of malar eminence deficiencies, whether congenital or acquired by trauma or disease.

The Pillar Malar Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that equivalent materials will be used in manufacturing. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.

Each Pillar Nasal Implant is indicated for the augmentation or reconstruction of nasal eminence deficiencies, whether congenital or acquired by trauma or disease.

The Pillar Nasal Implant is made from identical liquid elastomer materials and manufacturing processes as the predicate device. The raw materials are Nusil's MED 4211 unrestricted silicone fluid from Nusil Technologies, Inc. The durometers or hardness (shore A) of each implant will range from 5 to 30. The appearance is described as clear to opaque. Tensile strength averages 700 psi and the percent of elongation is over 400 percent.

ScarEase Sheets and Gel are indicated for use in the management of hypertrophic and keloid scars. ScarEase Sheets and Gel may prevent hypertrophic and keloid scarring.

ScarEase is a non-invasive medical device that reduces hypertrophic and keloid scars resulting from surgical procedures and traumatic events. ScarEase may soften, smooth and/or flatten scars. ScarEase Sheets will be individually packaged rectangular-shaped sheets (.0055 to .040″ thickness, by 1.5″ wide, by 4.0″ long) heat-sealed in polyethylene tubing, enclosed in a fold-over (labeled) outer covering with descriptive product information, enclosed with a package insert and sealed with shrinkwrap. ScarEase Gel will be available in 4 and 15 gram tamper-evident, labeled tubes. Each tube will be appropriately labeled to provide size, instructions for use and warnings. Each tube is generally placed into a descriptive display box stating product information and enclosed with a package insert. ScarEase sheets are made from Applied Silicone's calendared silicone sheeting material, durometer 50, shore A. ScarEase Gel is an amorphous clear gel made with Nusil Technology's MED 4210 4211 infused with polydimethysiloxane and silicone dioxide.