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KAT Implants System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implant can be placed in extraction sites or healed alveolar ridges. KAT Implants System 2.5mm implants are self-tapping titanium alloy threaded screws indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT Implants System 2.5mm implants may also be used for inter-radicular transitional application. KAT Implants System 3.0mm implants are indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate. KAT Implants System Abutments are intended to be used with KAT Implants System Dental Implants aid in prosthetic rehabilitation of the edentulous areas in maxilla and mandible.

Like the predicate KAT Implants 2.5mm and 3.0mm KAT Implants System Onepiece implants 2.5mm and 3.0mm display the following characteristics: a) have a threaded body and a tapered post with an internal threaded bore, b) have the same indications, c) are manufactured from the same material (Ti6Al4V ELI alloy), c) have the same diameters (2.5 and 3.0mm) and implant body lengths (10, 12 and 14mm), d) are packaged with the same materials and undergo the same sterilization process. KAT Implants System One-piece implants 2.5mm and 3.0mm implants are not designed to receive any abutments; they are designed to receive the crowns directly via cementation procedure. KAT Implants System One-piece implants are blasted with a soluble tricalcium phosphate blasting media. All materials and manufacturing processes are the same for all KAT Implants System Dental Implants. The fatigue testing was executed per ISO 14801:2007, Dentisty - Implants - Dynamic fatigue testing on endosseous dental implants on a 4.2mm width by 8.5mm length abutment with 20 ° angularity and a 3.0mm diameter implant, which is considered worst-case representation for KAT Implants System implants having 3.0mm or greater diameter. In view of a fatigue test results (samples were able to withstand 440 N of force over 5 million cvcles) and considering the fact that KAT Implants System One-piece Implants 3.0 and predicate KAT Implants System 3.0mm implants (K083544) have identical dimensions, no further fatigue testing was deemed necessary. Predicate one-piece implant devices (IMTEC Sedax MDI 1.8mm and Maximus 3.0mm Diameter Implant) are the same as One-piece implants 2.5 and 3.0 in respect to material composition, surface treatment, diameters and lengths (for the exception of One-piece implant 3.0 x 10). Predicate Maximus 3.0mm Diameter Implant is not provided in 10 mm length, but another predicate - KAT 3.0mm implant cleared under K083544 is provided in 10 mm length. Since predicate KAT Implants System 2.5mm implants (K083544) are approved for use with abutments of KAT Implants System, and considering the fact that KAT Implants System Onepiece Implants 2.5 and predicate KAT Implants System 2.5mm implants (K083544) have identical dimensions, no further fatigue testing was deemed necessary. KAT Implants System Angled Abutments are implant abutment devices intended to be distributed as part of the KAT Implants System. KAT Implants System currently consists of implants, abutments, and Class I accessory instrumentation cleared for marketing under Traditional 510(k) Pre-marketing Notification # K083544 and K101201. All dental abutments of the KAT Implants System are a) used for the same indication, b) are manufactured with the same Ti-6AI-4Va ELI alloy, c) undergo the same surface treatment and sterilization, d) packaged and labeled using the same packaging materials and Instructions for Use, and e) are intended to be assembled together during surgery utilizing the same locking-taper implant post/abutment connection, with the aid of the same KAT Implants System Class 1 accessories and instruments. Like the predicate KAT Implants System Straight (Prepable) Abutments with outside diameters 4.2mm 4.6mm and 5.4mm (all available only in 6.5mm length), KAT Implants System Angled Abutments which are subject of this 510(k), consist of a same-dimension internal hollow bore on one end for connection with the abutment-receiving post of the KAT Implants System Dental Implants. Like the abutment predicate, they are similarly designed to be retained by the KAT Implants System Dental Implants through the abutment-receiving post. A locking-taper connection is activated with a torque wrench set at 25 Ncm. KAT Implants System Ball Abutments are implant abutment devices intended to be distributed as part of the KAT Implants System. Like the predicate KAT Implants System Straight (Prepable) Abutments with outside diameters 4.2mm, 4.6mm and 5.4mm (all available only in 6.5mm length), KAT Implants System Ball Abutments which are subject of this 510(k), consist of a same-dimension internal hollow bore on one end for connection with the abutment-receiving post of the KAT Implants System Dental Implants. Like the abutment predicate, they are similarly designed to be retained by the KAT Implants System Dental Implants through the abutment-receiving post. A locking-taper connection is activated with a tapping force – the same method used to activate locking taper connection on the other predicate - KAT Implants System Implant Abutment 4.2x6.5. The material of construction (Ti-6Al-4Va ELI Alloy), all surface preparation, all packaging, labeling and sterilization of KAT Implants System Angled Abutments and Ball Abutments are the same as previously cleared KAT Implants Straight and Implant Abutments. The outside diameters are the same, however, dimensional characteristics which differ from KAT Implant System Straight Abutments predicate duly noted below: Angled Abutments: outside diameter availability in 4.6mm, and 5.4mm (within the range of previously cleared KAT Implant System Straight Abutments outside diameters), all with an 8.5mm length at 10° and 20° angulation. Mesial-distal width of Angled Abutment 4.2 10° and Angled Abutment 4.2 20° is 4.2mm. Ball Abutments: outside diameter availability in 4.2mm (within the range of previously cleared KAT Implant System Straight Abutments outside diameters), and lengths between 6.5 and 8.5mm at 0°, 10° and 20° angulation. The dimensional properties arising from differences in length between KAT Implants System Angled and Ball Abutments and the predicate KAT Implants System Straight Abutments were investigated by fatigue testing on KAT Implants System Angled Abutment 4.2mm x 8.5mm (20 ° anqularity) samples. The testing was executed per ISO 14801:2007, Dentistry - Implants -Dynamic fatique testing on endosseous dental implants. The use of a 4.2mm width by 8.5mm length Angled Abutment with 20° angularity is considered worst-case scenario representation for KAT Implants System abutments. All KAT Implants System Dental Implant and Abutment devices which are subject of this 510(k) and the listed predicate devices are substantially equivalent because they are: Manufactured using the same Titanium-6Aluminum-4Vanadium ELI alloy (certified to meet ASTM F136. Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications and biocompatibility requirements of Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments); Packaged with the same size and material primary packaging (in conformance with material and process requirements of ISO 11607, Packaging for Terminally-Sterilized Medical Devices and ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials); Are sterilized using the same sterilization process and sterility assurance level with SAL = 10-6 (per ISO 11137, Sterilization of Healthcare Products - Radiation). Have the same Indications for Use. Do not present any new dimensions and operating technology from endosseous dental implants and abutments already present in the market. The only modifications that were made are: 1. Angle of the predicate Straight Abutments was changed from 0° to 10° and 20°; 2. Length of the predicate Straight Abutments was changed from 6.5mm to longer lengths. New abutment devices were named Angled Abutments 4.2 20°, 4.6 20°, 4.2 10°, 4.6 10°, 5.4 10°. 3. Internal thread of the Straight Abutments was removed and a ball element was added. New abutment devices were named Ball Abutments 3.5, 4.5, 5.5, 3.5 10°, 4.5 10°, 4.5 20°, 4.5 20°, 4.5 20°, 4. Abutment receiving post of the predicate KAT Implants 2.5 and 3.0 was made longer. New implant devices were named One-Piece Implants 2.5 and 3.0; 5. Implant blasting media was changed from aluminum oxide to a soluble tricalcium phosphate. All KAT Implants System Implants will be blasted with soluble tricalcium phosphate and will retain original names.

KAT Implant System Dental Implants are indicated for restoration of edentulous maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. KAT Implant System Straight Abutment devices are intended to be used with KAT Implant System Dental Implants to aid in prosthetic rehabilitation. KAT Implant System (Dental Implants and Straight Abutment) is indicated for the restoration of edentulous areas in maxilla and mandible.

KAT Implant System Dental Implants (with outside diameters 6.0mm, 7.0mm and 8.0mm) and KAT Implant System Straight (Prepable) Abutments (with outside diameters 4.2mm, 4.6mm, 5.0mm, 5.4mm, and 6.4mm) are root-form, endosseous dental implant and implant abutment devices intended to be distributed as part of the KAT Implant System platform. KAT Implant System currently consists of implants, abutments, and Class I accessory instrumentation cleared for marketing under Traditional 510(k) Prc-marketing Notification # K083544. Like the predicate KAT Implant System Dental Implant with outside diameter 5.0mm, the KAT Implant System Dental Implants which are subject of this 510(k) are provided in lengths of 6.0mm, 8.0mm, and 10.0mm. External V-shaped thread is similarly utilized in these new sizes of KA I Implant System Dental Implants in order to screw the implants into the bone. Horizontal fins are also placed between the thread and the abutment receiving portion of these dental implants. The abutment receiving portion of all KAT Implant System Dental Implants consists of a 3.1mm outside diameter post with a 1.5 degree taper. All KAT Implant System Dental Implants are intended to be used with previously cleared KAT Implants System Implant Abutments, as stated in Instructions for Use. Like the predicate KAT Implant System Implant (Indexed) Abutments with outside diameters 4.2mm, 4.7mm, 5.5mm and 6.5mm, the KAT Implant Straight (Prepable) Abutments which are subject of this 510(k) consist of outside diameters within the predicate's range of outside diameters, and are 6.5mm in length. KAT Implant System Straight (Prepable) Abutments are similarly retained by the KAT Implant System Dental Implants through the abutmentreceiving post. A locking-taper connection activates the seating of the abutment to the implant with the help of a torque wrench.

KAT Implant System is intended to restore edentulous areas of maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. KAT 3.0mm implant is indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artifical teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-term intra-bony applications, such as providing support for transitional and crowns, bridges and dentures. KAT 2.5mm may also be used for inter-rollul br transitional application.

KAT implant system consists of dental implants, implant abutments, healing abutments, temporary abutments, screw retained framework abutment, spacer, cylinder, healing collar and the instruments for placement and restoration of the implants. KAT implants are supplied in 2.5, 3.0, 3.5, 4.3 and 5.0mm diameters. KAT 2.5 and 3.0mm implants are supplied in 10, 12 and 14mm length. IAAT 3.5mm is supplied in 8, 10, 12 and 14mm length. KAT 4.3 and 5.0mm inplants are supplied in 6, 8, 10, 12 and 14mm length. External V-shaped thread is utilized to screw the implants into the bone. Horizontal fins are placed in between the thread and the abutment receiving portion of 3.5, 4.3 and 5.0mm implace All implants have 3.1mm diameter 1.5 degree taper abutment receiving post. KAT abutments are available in 4.2, 4.7, 5.5 and 6.5mm diameter. KAT abutments can be attached to any KAT implant via locking taper connection.