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JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw.

JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE is intended for immediate function multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDEvolution Plus L and JDEvolution Plus LE implants with lengths of 18, 20, 22, 24, 26 mm are only indicated for multiple unit restorations in splinted applications with at least two implants when placed in the maxilla.

JDEvolution Plus L and LE, are tissue level implantable devices produced in commercially pure titanium, intended for surgical placement in the upper jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function.

JDEvolution Plus L and LE are endosseous dental implants intended for surgical placement in the upper jaw. JDEvolution Plus L and LE implants includes dental implant fixtures only.

JDEvolution Plus L and LE provide a means for prosthetic attachment partially or fully edentulous spans with multiple teeth utilizing delayed or immediate loading when good primary stability is achieved in order to restore patient chewing function.

The subject implant bodies are compatible with abutments cleared in K143142 and K233896

Knowledgeable clinicians are in charge for the following of a delayed instead immediate loading, evaluating the stability of the implant sites after the surgical operation.

The device insertion occurs at the end of the surgical procedure which consists in an osteotomy of the upper jaw.

JDEvolution Plus L and LE implants are single use devices, supplied sterile and that cannot be re-cleaned or re-sterilised.

JDEvolution Plus L and LE Implant System is a two-piece implant made of commercially pure titanium.

The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.

The connection is done through an internal hexagon: abutments and other accessories are exclusively designed for JDEvolution Plus L and LE Implant System.

Endosseous dental implant and abutment will represent the support, for the dentist, for building the artificial replacement tooth.

The artificial replacement tooth component is not part of this submission.

The main features of JDEvolution Plus L and LE Implant System are summarized in the table below:

JDEvolution Plus:
Materials: Titanium grade 4 (diameter 4.0)

Design:
General Features: Endosseous implant with connection with internal hexagon
Shape:
Collar: Machined gingival collar of 1,5mm length for all the lengths
Body: Double thread with 0.6 mm lead: straight cylindrical of 4,0 mm diameter for a total length (including collar) of 20 / 22 / 24 / 26mm. Tapered apex with bone cutting flutes.
Double thread with 1.2 mm lead: tapered body of 4,0 mm for a total length (including collar) of 18 / 20 / 22 / 24 / 26mm
Thread: Double thread with 0.6 mm or 1.2 mm lead
Abutment: To be connected with the Conical abutment cleared under K143142, K233896
Ti gr.5: Straight– angled 15° - angled 17° - angled 25°- angled 30°

Surface:
Collar: Machined, without any surface treatment
Body: Treated through sandblasting followed by acid etching (SLA) for the full length of the endosseous portion for all variants (the surface treatment is the same of the JDentalCare Implant System JDIcon cleared under K 182081)

Thread:
Body: Double thread
outline: trapezoidal
Thread lead: 0.6 mm (for tapered body version)
Thread lead: 1.2 mm (for straight cylindrical body version)
Self-Threading Capacity: Self-threading capacity in both direction

Dimensions:
Mean Diameter: 4.0 mm
Total Length: 18mm (only for JD Evolution Plus LE Implant), 20mm, 22mm, 24mm and 26mm
Implanted Length: 16.5mm (only for JD Evolution Plus LE Implant), 18.5mm, 20.5mm, 22.5mm and 24.5mm

Connection:
Shape: Internal hexagonal connection (Hexagon dimension of 2.425 mm)

Packaging:
Type of package: Blister with internal vial and protective cap for implants
External carton box as commercial packaging
Blister material: Tyvek
Polyester PET MO65
Vial material: Polystyrene Empera 116 vial closed with Eralyte PET cap

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