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Polibond is used to fix custom-fit prosthetic teeth in appropriately milled cavities of prosthetic bases.

The Subject device is a single-component self-cure bonding agent intended for use with milled PMMA denture base resins and milled PMMA denture teeth. The Subject device is used by a dental professional (dentist or dental technician) in the fabrication or repair of removable dentures. Dentures fabricated using the Subject device are one-time use, prescription-only devices. Polibond is intended for bonding Zirkonzahn PMMA materials such as Abro® Basic Multistratum® and Denture Gingiva Basic Mono resins in the manufacturing of dental prostheses. Abro® Basic Mono and Abro® Basic Multistratum® are dentin colored and used for milling denture Gingiva Basic Mono is a material used for milling denture bases.

ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers. ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.

All devices included in this submission are dental glass ceramics. There are different device types from three device groups: ICE Ceramics Group, ICE Stains Group, and Fresco Group. The devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. Specific accessories are supplied for mixing or changing viscosity.

ZIRKONZAHN.Implant-Planner is an implant planning software. The software imports and reads DICOM files from CT/CBCT scanners. The patient data is then transformed into 3D volume and different multi-planar 2D images for diagnosis and further implant and surgery guide planning with precise step by step instructions. The software is a stand-alone product that is not connected to any other medical device. Neither automatic diagnosis nor automatic disease detection is performed. The software is intended for use by dental professionals only and requires appropriate training for its use and knowledge in the practice of implantology.

ZIRKONZAHN.Implant-Planner is a fully-featured 3D imaging standalone application for implant planning and surgical guide design. ZIRKONZAHN.Implant-Planner supports all the common 3D medical imaging functionalities used by professionals to support their diagnosis. It includes various volume and surface rendering, masking and sculpting, MPR, 2D and 3D measurement and analysis tools. The software is provided in 2 versions and 2 modules: the first version is a full version (called "ZIRKONZAHN.Implant-Planner") that covers all applications for use, the second version is a basic/limited version (called "ZIRKONZAHN.Implant-Planner Practice") only for implant planning. The first module is a CAD/CAM STL Converter that converts DICOM data into STL files for further processing. The second one is the CAD/CAM Z-Tray for designing individual impression trays.

PRIME is used for manufacturing provisional crowns and bridge frameworks with up to two adjacent pontics in the anterior and posterior tooth area. ABRO 1 is intended for the fabrication of denture teeth; RESITON GINGIVA is intended for the fabrication of denture bases. PRIME TRANSPA, ABRO 1 TRANSPA and THERAPON TRANSPA are designed for the creation of bite splints, orthodontic splints and occlusal splints for bruxism.

The subject devices are blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental restorations. The devices are supplied in form of solid discs. All devices are composed of the same basic material, Polymethylmethacrylate (PMMA), and are available in various models that differ in color and dimension. The materials used for the submitted devices have a long history of safe use for the same or equivalent indications.

Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.

Zirkonzahn COLOUR LIQUID devices are used for coloring milled and finished presintered zirconia structures. Coloring is performed by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400 ℃. The Zirkonzahn COLOUR LIQUIDS are available in different colors and in different bottle sizes (20 ml, 50 ml, 100 ml).

Prettau®, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872. Prettau® 3, Prettau® 3 Coloured, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettaw® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872. The products have been developed for use with Colour Liquid, ICE Zirkon Stains and ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

The subject devices are composed of yttria-stabilized zirconia. They are available in different models that differ in form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.

TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to create reduced crowns and bridges (max. 2 pontics and min. 13 mm² connection cross-section), telescopic primary crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two pontics for reasons of stability. TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.

Tecno Med and the three Tecno Med Mineral devices are tooth-shade polymer discs based on polyether ether ketone (PEEK). These discs are available in a variety of shapes for different milling systems. For each device, there are two diameter variants, 95 mm and 98 mm. The discs with a diameter of 98 mm are additionally available with or without step. Moreover, each model is provided in different heights (8mm-30 mm). The users can choose according to their requirements and preferences among the different models. Tecno Med Mineral, Tecno Med Mineral Dentine as well as Tecno Med Mineral Tissue have the same indications for use, for the Tecno Med device there are other indications for use. These polymer discs are used by specifically trained personnel using CAD/CAM techniques.

For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.

ICE Zirkon Transluzent Plus is a dental porcelain system composed of zirconia based blocks which utilizes CAD/CAM technology for dental restoration fabrication.