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LW Pre-milled Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Compatible Implant: LW Implant, LW Narrow Implant Implant Diameter (mm): 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 (LW Implant), 3.75/3.77 (LW Narrow Implant) Platform Diameter (mm): 4.2/4.55/4.6/5.0/5.05/5.07/5.4/5.45/5.9/5.95/6.55/6.6/6.8/6.85/7.25/7.3/7.35/7.75/7.8/7.85 (LW Implant), 3.75/3.77 (LW Narrow Implant) LW Pre-milled Abutment is intended for use with the LW Implant System in the chart. All digitally designed abutments for use with LW Pre-milled Abutment are intended to be manufactured at the OSSVIS-validated milling center.

The LW Pre-milled Abutment is made of Ti-6AI-4V-ELI (ASTM F136), and it is provided non-sterile, which is required to be sterilized by the end-user before use. The subject abutment is indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. To produce patient-specific abutments, the cylindrical section of LW Pre-milled Abutment is customized by machining it using CAD/CAM technology. Each patient-specific abutment is custom-prescribed by the clinician. Abutment Name: LW Pre-milled Abutment, LW Narrow Pre-milled Abutment Uses: The Abutment is used as a support of prosthesis to restore the patient's chewing function. Surface Treatment: N/A Fixture Connection: Hex 2.48 / Non-Hex (LW Pre-milled Abutment), Hex 2.08 / Non-Hex (LW Narrow Pre-milled Abutment) LW Pre-milled Abutment is compatible with following Implant System. 1) LW Pre-milled Abutment Proprietary Name: LW Implant System Pre-market Submission Number: K223924 Compatible Implant Device Name: LW Implant Implant Interface Connection Type/Size (mm): Internal Connection Type/2.5 Type of Implant-Abutment Connection: Hex/Non-Hex LW Pre-milled Abutment is used with an LW Abutment Screw in LW Implant System(K223924). 2) LW Narrow Pre-milled Abutment Proprietary Name: LW Narrow Implant System Pre-market Submission Number: K233808 Compatible Implant Device Name: LW Narrow Implant Implant Interface Connection Type/Size (mm): Internal Connection Type/2.1 Type of Implant-Abutment Connection: Hex/Non-Hex LW Narrow Pre-milled Abutment is used with an LW Narrow Abutment Screw in LW Narrow Implant System(K233808). The design envelope for Patient-Specific Abutment are as follows: Diameter: 4.5-7.0 mm (LW Pre-milled Abutment), 4.0, 4.5 mm (LW Narrow Pre-milled Abutment) Length: Straight: 7.9 - 16.9 mm, Angled: 12.9, 14.9 mm (LW Pre-milled Abutment) Minimum gingival height: 1.0 mm (LW Pre-milled Abutment) Maximum gingival height: 7.0 mm (LW Pre-milled Abutment) Minimum wall thickness: 0.4 mm (LW Pre-milled Abutment) Minimum post height for single-unit restorations (length above the abutment collar / gingival height): 4.0 mm (LW Pre-milled Abutment) Maximum angulation: 30° (LW Pre-milled Abutment)

The LL Implant System is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

The LL Implant System consists of a one-piece implant and temporary cap. The LL Mini Onebody Implant is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: submerged type, tapered body, sided cutting edge. The LL Temporary Cap is made Polyoxymethylene (ASTM F1855) without any surface treatment.

The LW Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW Implant System - Abutment consists of the LW Solid, LW Angled, and LW Vis Abutment. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136), and they are provided non-sterile, which are required to be sterilized by the end-user before use. The LW Implant System – Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924.

The LW UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW UCLA Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924. The Abutment is used as a support of prosthesis to restore the patient's chewing function. It is made of Co-Cr-Mo alloy (ASTM F1537) in the main body and POM (ASTM F1855) in the plastic sleeve, and it is provided non-sterile, which are required to be sterilized by the enduser before use. The dimensions are O 4.5 (D) x 10.0 mm (P/H, when the main body and plastic sleeve are connected.).

The LW Retaction Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The LW Retraction Cap is a component of the LW Implant System (K223924), and it is used with the LW Solid Abutment and LW Vis Abutment of the LW Implant System. Used to protect the LW Solid Abutment and LW Vis Abutment in the oral cavity. The LW Retraction Cap is made of POM(Polyoxymethylene(ASTM F1855)) and provided non-sterile, which is required to be sterilized by the end-user before use. The dimensions of subject device are as following: Ø 5.0, 6.0, 6.1, 6.7, 7.2, 7.7, 8.2, 8.7 mm (D) x 5.5, 7.0, 8.5 mm (L).

The LW Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw. The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment. The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).