A-A-51969
When use in accordance with manufacturer’s instruction, moderate hand or closing pressure shall displace the pressure indicating paste, clearly outlining excessive pressure areas to permit precise adjustments. The paste and emulsion shall be suitable for use in contact with the oral mucosa. The compound shall clean readily from dentures, crowns, and inlays after normal use. The materials shall exhibit characteristics of long shelf life.
The materials shall not have either an unpleasant odor or flavor.
The paste shall have a smooth, creamy white appearance.
Consistency. The silicone paste shall have penetration values between 261 and 315 when tested in accordance with American Society for Testing and Materials (ASTM) Designation D 217. The consistency shall remain constant under ambient temperature conditions.
Material. The paste shall be a homogeneous, silicone mixture colored white by a suitable coloring agent. The mixture shall be free-flowing under slight pressure. The silicone emulsion shall be suitable for use as a spray which acts as a wetting agent following application of the paste. The pressure indicating compound shall contain no ingredients which are toxic or irritating to the oral tissues.
Brush. (replacement). The brush shall consist of fibers held by a tubular metal handle. The handle shall be crimped on one end to hold the fibers securely. The brush shall contain adequate fibers to spread the compound. The fiber bundle shall be 3/8 ± 1/16 inch wide and 3/4 ± 1/16 inch long. The tube shall be 1/4 ± 1/32 inch in diameter, with an overall length of 3-1/4 ± 1/8 inches. The fibers shall be made from natural animal bristles.
Wormanship. Pressure indicating compound shall be free of lumps or granules or from any defect which detracts from its appearance or impairs its serviceability. The brush shall be free of stiff, inflexible or loose fibers or any defect which detracts from its appearance or impairs its serviceability.
Unit. Package (PG). One package containing 1/2 oz of silicone, 2 oz silicone emulsion, atomizer, brush, and instructions, or one package containing 12 brushes, as specified, constitutes one unit.
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