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ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices. ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time. ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.

The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device trays are to be used to organize and protect the instruments 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 wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone. The subject device includes two instrument trays that have the same size (same lid, base, and enclosed volume) and two inner tray configurations.

Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.

Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs. The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136. The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).

Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations. The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws. The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK). The subject device implants are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, Zirconia Locator-type abutments are provided in straight and 15° angled designs. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia. The subject device implants and Healing Cap are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.

Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading.

Z5c is a two-piece, root-form, threaded implant and abutment system made from yttria-stabilized zirconia (Y-TZP). The Z5c implant endosseous surface is grit blasted and laser modified. The Z5c implant and corresponding abutment are bonded together using a self-adhesive resin cement. The Z5c implant system is designed for single or multiple tooth restorations. Z5c implants are provided in two endosseous diameters (4.0 and 5.0 mm) and each diameter is provided in three lengths (8, 10, and 12 mm). Z5c abutments are provided in two designs, straight and angled 15°.

Zsmlb: Z mlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z<mlc: 2 smlc implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Zamle implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

The purpose of this submission is to expand the Z-Look3 Evo SLM implant line (K 120793) to include two implant designs indicated for denture attachment. The Z5mlb and Z5mlc are onepiece, root-form, threaded implants made from yttria-stabilized zirconia (Y -TZP). Zsmlb and 25mlc implants are designed for full or partial denture restorations. Z5mlb implants are provided in two diameters (3.6 and 4.0 mm) and two endosseous lengths (8 and 10 mm). Zsmlc implants are provided in one diameter (4.0 mm) and one endosseous length (10 mm).

Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z-Look3 Evo SLM is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). The Z-Look3 Evo SLM surface is grit blasted with medical grade Al20 and laser modified. Implants are available in three diameters (3.6, 4.0 and 5.0 mm) and four lengths (8, 10, 11.5 and13 mm). Z-Look3 Evo SLM implants are designed for single or multiple tooth restorations. Z-Look3 Evo SLM implants are a modification to Z-Look3 implants. The laser modified surface has been added to increase surface roughness and, therefore, the surface area available for contact with bone.

Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z-Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies. Contraindications for the Z-Look3 Dental Implant Ø 3.25 mm: - Restoration of posterior teeth in the upper or lower jaw - Single-tooth restoration of canines and central incisors in the upper jaw

The Z-Look3 Dental Implant is a one-piece, self tapping, threaded, root form endosseous dental implant. Z-Look3 Dental Implants are offered in three diameters (3.25 mm, 4.0 mm, 5.0 mm) and four lengths (10 mm, 11.5 mm, 13.0 mm, 14.0 mm).