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The Adin Long Dental Implant System is intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to restore the patient's chewing function in fully or partially edentulous patients. The implants are intended for multi-unit, full-arch, screw-retained prosthetic restorations and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Adin Touareg-OS Zygomatic Dental Implants are intended for placement in the zygomatic bone in patients with severe atrophic maxilla; they may be used with implant-level framework designs with 45° to 60° angulation.

Adin Long Dental Implant System is an extension of previously cleared dental implant devices, designed to expand the product offering and provide additional options for dental restoration procedures. Specifically, this submission seeks marketing clearance for the following implants and abutments:

(1) Adin TouaregTM-OS Zygomatic Dental Implants:

• Outer diameter of 4.2 mm
• Available Lengths: 35.0mm, 37.5mm, 40.0mm, 42.5mm, 47.5mm, 50.0mm, 52.5mm and 55.0mm.

(2) Adin Long Dental Implant System -RS TMATM:

• Connection: RS
• Diameter: 4.9 mm
• Available Configurations (Angle / Gingival Height):
  • 45° / 4 mm
  • 52° / 5 mm
  • 60° / 5 mm

ADIN TOUAREGTM-OS ZYGOMATIC DENTAL IMPLANTS:

Adin TouaregTM-OS Zygomatic dental implants is a threaded, root-form dental implants made of biocompatible Ti-6Al-4V ELI alloy complying with ASTM F136-13(2021)e1 – "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and ISO 5832-3:2021 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

Adin TouaregTM-OS Zygomatic Dental Implants are used for surgical placement through the maxillary arch and anchored in the zygomatic bone to provide support for prosthetic devices such as artificial teeth to restore the patient's chewing function in edentulous or partially edentulous patients only with severe atrophic maxilla.

Adin TouaregTM-OS Zygomatic Dental Implants are intended for extra-maxillary extra-sinus procedures, and their use is limited to ZAGA-4 extra-maxillary implant placement.

The device is intended to be used under the following clinical conditions and surgical parameters:

• Multi-unit reconstruction (TMA), with a rigid splinting of minimum two implants.
• For an edentulous/full mouth restoration, should be used together with at least two standard implants.
• It should be used only in patients with severe atrophic maxilla.
• Extra-maxillary extra-sinus procedures intended to be anchored in the zygoma bone
• One stage or two stage surgical operation.
• Immediate loading (function) is applicable provided that stability requirements are satisfied.

All TouaregTM-OS Zygomatic implants have OsseoFixTM surface treatment which was previously cleared under Adin's 510(k) K212775 for Adin's legally marketed Adin Short Implants and remained unchanged since these clearances.

ADIN TOUAREGTM-OS ZYGOMATIC IMPLANTS – RS TMATM

The TMATM system is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.

Adin TouaregTM-OS Zygomatic implants are intended for TMA in combination with a rigid splinting of a minimum of 2 conventional dental implants.

Screw-retained abutments are made of titanium alloy 6Al-4V ELI complying with ASTM F136-13 and ISO 5832-3:2021 - Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

The TMA system is used to elevate seating platform of restoration when restoration at implant level is not indicated or practical due to the depth or emergence angle of the implant.

The Adin TouaregTM-OS Zygomatic Implants - RS Angled TMATM (45°, 52°, 60°) are only intended for use with the proposed Adin TouaregTM-OS Zygomatic Dental Implants.

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