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The Nobel Biocare PureSet™ Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment. Nobel Biocare PureSet™ Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization container, sterilization pouch or sterilization wrap. Sterilization validations for the worst-case PureSet™ Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles. The PureSet™ Trays were validated for a maximum load of 1635 grams (Trefoil™ PureSet™ Tray), 1122 grams (NobelActive® / NobelParallel™ CC PureSet™ Tray), 1063 grams (NobelReplace® CC PureSet™ Tray), 454 grams (Nobel Biocare N1™ PureSet™ Tray), 486 grams (Prosthetic PureSet™ Tray), 1143 grams (NobelActive® Guided PureSet™ Tray), 1146 grams (NobelParallel™ CC Guided PureSet™ Tray), 1176 grams (NobelReplace® CC Guided PureSet™ Tray), and 1035 grams (NobelSpeedy® Groovy® / Brånemark System® Mk III TiUnite / Replace Select™ TC PureSet™ Tray) and 1202 grams (NobelZygoma PureSet™ Tray). Method: Steam Sterilization (Moist Heat Sterilization) for Wrapped Instruments Cycle: Dynamic-Air-Removal (fractionated vacuum), Gravity-Displacement Temperature: 132°C (270°F), 132°C (270°F) Exposure time for a single-use pouched device: 4 minutes (full-cycle), 15 minutes (full-cycle) Minimum drying times: 20 minutes, 30 minutes

PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surgical and reprocessing procedures. PureSet Trays are not intended to maintain sterility on their own; they are intended to be used in conjunction with an FDA cleared sterilization wrap, pouch, or container. All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents. PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities.

Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.

Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.

· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base: The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation. · Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.

NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines: - NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and - - -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following: a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing. NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3. The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).

N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.

N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.

Nobel Biocare PureSet Trays are used in healthcare facilities to store and organize Nobel Biocare surgical/prosthetic instruments and components during cleaning/sterilization and during implant/prosthetic treatment. Nobel Biocare PureSet Trays are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA cleared sterilization pouch, or sterilization wrap. Sterilization validations for the worst-case PureSet Tray included surgical instruments such as torque wrenches, implant drivers, direction indicators, drills, screw taps, screwdrivers, and irrigation needles. The PureSet Trays were validated for a maximum load of 1635 grams (Trefoil PureSet Tray), 1122 grams (NobelActive / NobelParallel CC PureSet Tray), 1063 grams (NobelReplace CC PureSet Tray), 454 grams (Nobel Biocare N1™ PureSet Tray), 486 grams (Prosthetic PureSet Tray), 1143 grams (NobelActive Guided PureSet Tray), 1146 grams (NobelParallel CC Guided PureSet Tray), 1176 grams (NobelReplace CC Guided PureSet Tray), and 1035 grams (NobelSpeedy® Groovy / Brånemark System® Mk III TiUnite / Replace SelectTM TC PureSet™ Tray). | Method | Steam Sterilization (Moist Heat Sterilization)<br>for Wrapped Instruments | | |--------------------------------------------------|---------------------------------------------------------------------------|-------------------------| | Cycle | Dynamic-Air-Removal<br>(fractionated vacuum) | Gravity-Displacement | | Temperature | 132°C (270°F) | 132°C (270°F) | | Exposure time for a single-use<br>pouched device | 4 minutes (full-cycle) | 15 minutes (full-cycle) | | Minimum drying times | 20 minutes | 30 minutes |

PureSet Trays are reusable surgical trays to be used in combination with Nobel Biocare surgical instruments and components. PureSet Trays are used to organize and store the instruments and components during both surqical and reprocessing procedures. PureSet Trays are not intended to maintain sterility on their own; they are intended to be used in conjunction with an FDA cleared sterilization wrap, pouch, or container. All components of the PureSet Tray are perforated with an evenly-distributed hole pattern and are designed to be used for sterilization via steam sterilization. Because the PureSet Trays are perforated, an FDA-cleared sterilization wrap, pouch, or container must be used during sterilization and storage to maintain the sterility of the contents. PureSet Trays are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Principle of Operation / Mechanism of Action: PureSet Trays consist of multiple components (tray base, lid, and plate) integrated into a single unit which is used to organize instruments during surgical procedures and to protect the instruments during transportation, reprocessing, and storage.