POLIDENT PINK CAD/CAM DISC INSTRUCTIONS FOR USE CHARACTERISTICS Vickers hardness: 26,60 HV Flexural strength: > 114 MPa E-Module: > 2771 MPa Residual monomer: < 1% DIMENSIONS Diameter: PINK BASIC: 95 – 100 mm PINK FULL DENTURE: 95 - 98,5 mm Thickness: PINK BASIC: 25 – 32 mm PINK FULL DENTURE: 30 mm COLOURS / SHADES PINK BASIC: Pink or other Pink shades available upon request PINK FULL DENTURE: o Denture base: Pink o Dentin: A1, A2, A3 or other shades available upon request CONTRAINDICATIONS Contraindications in the case that the patient is known to be allergic to any of the disc ingredients. SIDE EFFECTS Systemic side effects or adverse events are not known up to now. In individual cases local allergic reactions to methyl methacrylate materials have been reported. INDICATIONS FOR USE Fabrication of dentures POLIDENT PINK CAD/CAM DISCS TYPE BASIC INSTRUCTIONS FOR USE The denture base is designed with suitable CAD dental software. The disc is fixed in the disc holder in the milling machine. The previously designed STL-file with third party software is loaded in the machine CAM software. Milling strategies for PMMA must be considered according to the milling machine instructions. After milling the denture, it is separated from the disc with standard grinding tools. Artificial teeth are attached on denture base with PMMA resin or light curing composite material according to manufacturer`s instructions. The artificial teeth must be roughened and prepared according to manufacturer`s instructions. The disc does not require special treatment in the case of using PMMA resin bonding but usually requires a prior treatment in the case of using composite material bonding according to manufacturer`s instructions. After the teeth are attached the denture can be finished with standard grinding and polishing tools for PMMA resin. POLIDENT PINK CAD/CAM DISCS TYPE FULL DENTURE INSTRUCTIONS FOR USE Full dentures and other structures are designed in CAD Software. Height of dentine layer: 12 mm, height of denture base layer: 18 mm. The disc is fixed in the disc holder in the milling machine. The previously designed STL-file with third party software is loaded in the machine CAM software. Milling strategies for PMMA must be considered according to the milling machine instructions. After milling the denture, it is separated from the disc with standard grinding tools. A 5-Axis milling machine is required, to mill undercut areas. An offset of about 1mm should be designed on the gum part around the teeth margin to be later covered with pink cold curing acrylate or composite. The amount of the material should be thick enough to cover the line between the pink and dentin. As the end result a natural looking transition of pink/white should be achieved. Always use composite or acrylic resin in accordance with the manufacturer's instructions. After characterization of the gum part and teeth, the denture is treated and polished by conventional process. COMPOSITION PINK CAD/CAM discs type BASIC and FULL DENTURE are made of polymethylmethacrylate (PMMA) and pigments. WARNINGS AND PRECAUTIONS Avoid contact with powder generated by final working. Wear respiratory protective device in case of dust formation. Ensure the area is well ventilated. Pay attention not to overheat the material. PINK CAD/CAM disc is not used sterile. In case of known allergies or hypersensitivity to acrylic materials do not use the product. In case that any serious incident has occurred in relation to the device it should be reported to the manufacturer (Polident d.o.o.; [email protected] ) and the competent authority of the Member State, where the user is established. STORAGE AND DISPOSAL Keep in dry storage. Keep out of the reach of children. Disposal should be made in accordance with local, state and national legislation. CAUTION Federal law restricts this device to sale by or on the order of a dentist. Release date: 1.10.2019 No.: 0200214 Polident d.o.o. Slovenija, Volčja Draga 42, 5293 Volčja Draga, Slovenija T:+386 53304840, F:+386 53304870 E-mail: polident@polident