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Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact™ Dental Implant System 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions. All digitally designed Kontact™ Dental Implant System CAD/CAM abutments are intended to be sent to a Biotech Dental validated milling center for manufacture.

The purpose of this submission is to expand the marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants and prosthetic components for single-unit, multi-unit, and overdenture restorations to include two additional implant body designs, new Narrow Conical and Conical abutments, hand-milled FitPost abutments, inserts for the previously cleared UniPost abutments and CAD/CAM Titanium base and Titanium Blank, dental implant abutments. The Kontact™ Dental Implant System Subject device include two implant designs: Kontact S+. The Kontact S and compatible Kontact implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The body diameter for each implant is equal to the implant platform diameter. The 3.0 mm body implants have a smaller diameter and unique restorative interface. The 3.6 mm, 4.8 mm, and 5.4 mm implants share the same restorative interface. The Kontact S implants are provided in lengths ranging from 8 mm to 16 mm. The Kontact S+ implants are provided in four body diameters: 4.0 mm, 4.5 mm, 5.0 mm, and 5.5 mm. The 4.0 mm body diameter implants have an implant platform diameter of 3.6 mm and 5.5 mm body diameter implants have an implant platform diameter of 4.2 mm diameter implants are available in both 3.6 mm and 4.2 mm implant platform diameters. All Kontact S+ implants share restorative interface as the 3.6 mm and larger diameter Kontact S implants. The Kontact S+ implants are provided in lengths ranging from 8 mm to 12 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. Kontact S and Kontact S+ implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ASTM F67 and ISO 5832-2. The endosseous threaded surface of the Kontact S+ implants are gritblasted with resorbable beta-tricalcium phosphate (β-ΤCP) particles. Grit-blasting of the Kontact S+ implants create a roughened surface which provides an increase in total contact area of the implant surface to facilitate osseointegration. The Subject device prosthetic components include seven implant abutment designs: Straight Conical, 30° Angulated Conical (indexed and non-indexed), Titanium Base, Titanium Blank and FitPost. The abutments designs are compatible with the Kontact, Kontact S+ implants. All Subject device abutments are manufactured titanium alloy conforming to ASTM F136 and ISO 5832-3.

Drill Stop Kit is intended to be used to enclose drill stops that are to be sterlized by a health care provider. Drill Stop Kit is intended to allow sterilization of the enclosed medical devices. Drill Stop Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Drill Stop Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum)- Exposure at 132 °C for 4 minutes and 20 minutes dry time. Drill Stop Kit is intended for sterilization of non-porous loads. Drill Stop Kit is recommended not to be stacked during sterilization. The combined weight of the Drill Stop Kit and the associated devices is 199.8 grams. The weight of the empty Drill Stop Kit is 192.6 grams. Prosthetic Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Prosthetic Kit is intended to allow sterilization of the enclosed medical devices. Prosthetic Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Prosthetic Kit is to be enclosed in a sterlization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Prosthetic Kit is intended for sterilization of non-porous loads. Prosthetic Kit is recommended not to be stacked during sterilization. The combined weight of the Prosthetic Kit and the associated instruments is 178.8 grams. The weight of the empty Prosthetic Kit is 141.8 grams Healing Screws Kit is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Healing Screws Kit is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.). Healing Screws Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) - Exposure at 132 °C for 4 minutes and 20 minutes dry time. Healing Screws Kit is intended for sterilization of non-porous loads. Healing Screws Kit is recommended not to be stacked during sterilization. The combined weight of the Healing Screws Kit and the associated instruments is 203.1 grams. The weight of the empty kit Healing Screws Kit is 168.9 grams. Kit for Healing Screws Kontat Perio Level is intended to be used to enclose healing screws that are to be sterilized by a health care provider. Kit for Healing Screws Kontat Perio Level is intended to allow sterilization of the enclosed medical devices. Healing Screws Kit, Perio Level requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.). Kit for Healing Screws Kontat Perio Level in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time. Kit for Healing Screws Kontat Perio Level is intended for sterilization of non-porous loads. Kit for Healing Screws Kontat Perio Level is recommended not to be stacked during sterilization. The combined weight of the Kit for Healing Screws Kontat Perio Level and the associated instruments is 200.0 grams. The weight of the empty Kit for Healing Screws Kontat Perio Level is 169.0 grams. Scanbodies Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Scanbodies Kit is intended to allow sterilization of the enclosed medical devices. Scanbodies Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Scanbodies Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Scanbodies Kit is intended for sterilization of non-porous loads. Scanbodies Kit is recommended not to be stacked during sterilization. The combined weight of the Scanbodies Kit and the associated instruments is 259.7 grams. The weight of the empty Scanbodies Kit is 233.9 grams. Pick-up Impression Coping Cica Kit is intended to be used to enclose pick-up impression copings that are to be sterilized by a health care provider. Pick-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pick-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Pick-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes and 20 minutes dry time. Pick-up Impression Coping Cica Kit is intended for sterilization of non-porous loads. Pick-up Impression Coping Cica Kit is recommended not to be stacked during sterilization. The combined weight of the Pick-up Impression Coping Cica Kit and the associated instruments is 338.0 grams. The weight of the empty tray Pick-up Impression Coping Cica Kit is 291.4 grams. Pop-up Impression Coping Cica Kit is intended to be used to enclose pop-up impression copings that are to be sterilized by a health care provider. Pop-up Impression Coping Cica Kit is intended to allow sterilization of the enclosed medical devices. Pop-up Impression Coping Cica Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Pop-up Impression Coping Cica Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) = Exposure at 132 °C for 4 minutes and 20 minutes dry time. Pop-up Impression Coping Cica Kit is intended for sterilization of non-porous loads. Pop-up Impression Coping Cica Kit is recommended not to be stacked during sterilization. The combined weight of the Pop-up Impression Coping Cica Kit and the associated instruments is 317.1 grams. The weight of the empty kit Pop-up Impression Coping Cica Kit is 270.9 grams. Multi Kontact Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Multi Kontact Surgical is intended to allow sterilization of the enclosed medical devices. Multi Kontact Surgical requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.) Multi Kontact Surgical is to be enclosed in a sterlization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time. Multi Kontact Surgical is intended for sterilization of non-porous loads. Multi Kontact Surgical is recommended not to be stacked during sterilization. The combined weight of the Multi Kontact Surgical and the associated instruments is 580.7 grams. The weight of the empty Multi Kontact Surgical is 449.6 grams. Try-in Abutment Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Try-in Abutment Kit is intended to allow sterilization of the enclosed medical devices. Try-in Abutment Kit requires the use of a double pouch to maintain the sterlity of the enclosed devices (pouch must be FDA cleared in the U.S.). Try-in Abutment Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time. Trv-in Abutment Kit is intended for sterilization of non-porous loads. Try-in Abutment Kit is recommended not to be stacked during sterilization. The combined weight of the Try-in Abutment Kit and the associated devices is 469.5 grams. The weight of the empty Try-in Abutment Kit is 463.8 grams AtlaSurgery Guided Surgery Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. AtlaSurgery Guided Surgery Kit is intended to allow sterilization of the enclosed medical devices. AtlaSurgery Guided Surgery Kit requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.). AtlaSurgery Guided Surgery Kit is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) = Exposure at 132 °C for 4 minutes and 20 minutes dry time. AtlaSurqery Guided Surgery Kit is intended for sterilization of non-porous loads. AtlaSurgery Guided Surgery Kit is recommended not to be stacked during sterilization. The combined weight of the AtlaSurgery Guided Surgery Kit and the associated instruments is 689.2 grams. The weight of the empty AtlaSurgery Guided Surgery Kit is 476.0 grams. Pilot Drills Kit for Guided Surgery is intended to be used to group other medical devices that are to be sterilized by a health care provider. Pilot Drills Kit for Guided Surgery is intended to allow sterlization of the group medical devices. Pilot Drills Kit for Guided Surgery requires the use of a double pouch to maintain the sterility of the enclosed devices (pouch must be FDA cleared in the U.S.). Pilot Drills Kit for Guided Surgery is to be enclosed in a sterilization double pouch that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: In the U.S. only, dynamic air removal (pre-vacuum) – Exposure at 132 °C for 4 minutes dry time. Pilot Drills Kit for Guided Surgery is intended for sterilization of non-porous loads. Pilot Drills Kit for Guided Surgerv is recommended not to be stacked during sterilization. The combined weight of the Pilot Kit for Guided Surgery and the associated instruments is 39.4 grams. The weight of the empty Pilot Drills Kit for Guided Surgery is 36.8 grams.

The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner trav (if applicable), and a lid (cover). The subject device trays are to be used to organize and protect the dental healing screws, try-in abutments, instruments, and accessories that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared pouch to maintain sterility. The subject device includes a total of 10 sizes (same lid and base and enclosed volumes), and a total of 11 tray configurations. The subject device has seven (7) trays that are 2-piece plastic trays manufactured from Polyphenylsulfone (Radel® R-5000) for the lid and Polypropylene (PPHS) or Polysulfone for the base. The subject device has three (3) trays that are 3-piece plastic trays manufactured from Polyphenylsulfone (Radel R-5000) with silicone grommets. The subject device has one (1) tray that is a 2-piece metal tray manufactured from stainless steel.

Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.

The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).