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KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams. The weight of the empty KIT WT SNIPER is 620 grams. The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT SNIPER JSI KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams. The weight of the empty KIT WT SNIPER JSI is 620 grams. The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT INTERNA KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams. The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT VEGA KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT VEGA and the associated instruments is 820 grams. The weight of the empty KIT WT VEGA is 620 grams. The KIT WT VEGA is exclusively indicated to assist in the installation of the VEGA® family and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT ESSENTIAL KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterlization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 ℃ for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams. The weight of the empty KIT WT ESSENTIAL is 620 grams. The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT MEDGUIDE® KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic ar removal steam sterilization - Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams. The weight of the empty KIT MEDGUIDE® is 160 grams. The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.

The subject device trays are designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the tray by the healthcare provider . The base, inner trav, and lid components are designed to be integrated into a single unit (the complete trav) which contains and protects the interior components during sterilization. The lid latches to the base to secure the tray into a single unit. The base, inner tray, and lid components are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam) sterilization and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone and AISI 316L stainless steel. Holders of various geometries to position instruments in the kits are manufactured from silicone. The subject device trays are summarized in the following table Summary of Tray Dimensions and Contents.

Klockner Abutments are intended for use in dental implants to provide a support structure so that the edentulous or partially edentulous patients will regain their masticatory and aesthetic functions. All digitally designed abutments for use with Klockner TiBase Abutments are intended to be sent to a SOADCO S.L. validated milling center for manufacture.

The abutments consist of healing abutments, temporary abutments, straight abutments, and an overdenture attachment system that consists of abutments, denture housings, and retention inserts, and TiBase abutments with screws.

Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDAcleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle: - o Pre-vacuum Steam at 134℃ for 4 minutes with 15 minutes drying time. The trays are intended for sterilization of metal and thermoplastic loads.

Klockner Surgical Box is a reusable rigid sterilization cassette or organizing tray intended for the purpose of containing reusable (and in some cases, non-reusable) devices for sterliization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior components during sterilization. Under the device trade name "Klockner Surgical Box", two different sets of sterliization surgical boxes are presented: (Both sets differ in the way the plastic is molded). - Injection molding sterilization cassettes ● - Machined sterilization cassettes ●

The KLOCKNER® VEGA® dental implant system is indicated to replace missing teeth in single and multiple unit applications within the mandible or maxilla. Implants can be for immediate placement and function in extraction sites and partially or completely healed alveolar ridge situations, when good primary stability is achieved and with appropriate occlusal loading. Different loading protocols (immediate, early or delayed) can be applied in partially or totally edentulous patients. The prosthetic restorations can be single-unit or multiple-unit restorations. The Ø 3.0 mm implants should only be used for unit restorations for maxillary lateral incisors and mandibular lateral and central incisors.

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The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.

Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in: - Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment. - Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration. - Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting. - Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting. - Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique. All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.

The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abulments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ECK, Essential ECK, Essential EC 1.5, SK2 and NK2.

Klockner Dental Implant Abutments consist of a group of prosthetic components placed into dental implants to aid in prosthetic rehabilitation. According to their function, they are classified in: - Healing caps, are manufactured in Titanium Alloy, intended to assist in healing or modification of the adjacent tissues for internal octagonal connection system. - Protective caps, manufactured in PMMA and Titanium Alloy intended to protect abutments when choosing direct oral impression for internal octagonal connection system. - Temporary abutments, manufactured in Titanium cp, Titanium Alloy and Titanium cp + -PMMA, intended to support provisional prosthetic restorations for internal octagonal connection system. - Angled abutments, manufactured in Titanium cp and Titanium Alloy, intended to retain definitive dental prosthesis. Used when it is necessary to correct the implant axis, for internal octagonal connection system and external hexagonal connection system. - Straight abutments, manufactured in Titanium Alloy and Titanium cp, intended to retain definitive dental prosthesis for internal octagonal connection system. Includes Titanium Octacone Scan abutment, a Titanium Base for CAD/CAM. This base is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. - Overdenture abutments, manufactured in Titanium Alloy and POM C, intended to retain removable dental prosthesis for internal octagonal connection system and external hexagonal connection system. Healing caps, protective caps and temporary abutments are used for a limited time, while angled abutments, straight abutments and overdenture abutments are intended for a definitive use.

The Klockner Essential implant system is especially designed for surgical insertion into the bone to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection. Immediate loading is appropriate for the Essential Cone 1.5 implants when good primary stability is achieved with appropriate occlusal loading. 8mm Implants are not indicated for use as single implants and for immediate load.

The Klockner Essential Cone 1.5 implant system consists of a implants to restore the mastication system. The different EC 1.5 are available in four different diameters: 3.5mm, 4.0mm, 4.5mm and 4.8mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height. The Essential Cone implants are fitted with an internal octagonal conical connection. The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants. Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations. 8mm Implants are not indicated for use as unitary implants and for immediate load.

The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.

S3M Klockner implants are a dental implant which consist of a small conical fixture (the root-form configuration). This implant enabling to be used as a support fitting when the gap to be replaced is not sufficient for a standard fitting (Ø 4.2 mm shoulder), or in areas of aesthetic concern, where the long-term preservation of the papilla is very important, such as the upper lateral incisors and lower incisors.

The S3M Klockner implant are an endosseous implant, are a device made of Grade 3 commercially pure titanium , which consist of a small conical fixture (the root-form configuration), perhans eigth to fourteen millimetres in length that have a shot peening process and a pasivated surface. Are available in diameter 3.1mm.