Search Results

The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then pickling to roughen the surface. The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.

The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

The Luna Dental Implant System is a device of pure titanium (ASTM F67) and titanium alloy (ASTM F1136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. This 510k is intended to add the new models of the following abutments to the Luna Dental Implant System: Healing Abutment I, Duo Abutment, Duo Plus Abutment, Temporary Abutment.

The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

The S-Mono is made of Titanium Alloy (ASTM F136) as the raw material. This device supports dental prosthesis such as an artificial tooth by surgically implanting it in the alveolar bone of the mandibular anterior region with a narrow tooth gap, and is intended to restore the patient's chewing function. It is one-body type which includes fixture and abutment. The surface of the fixture is treated using RBM (Resorbable Blast Media). It is roughened by blasting with hydroxyapatite powder and then pickling with nitric acid. The Temporary Cap is made of POM (Polyoxy Methylene) and intended to relieve the patient's foreign body sensation and protect the abutment part while the dental prosthesis is being manufactured. This cap is placed over the abutment part and is used temporarily before the dental prosthesis is placed. The material, dimension, and intended use of the subject devices are similar to devices currently marketed worldwide.

The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Luna Dental Implant System - Healing Abutment is to be connected to the implant and is to heal gingiva before setting abutment on the implant in the oral cavity. It is made of commercially pure titanium alloy Gr4. It offers narrow and regular platform types, and the narrow type has anodizing surface treatment in purple to be distinguished from the regular type.

The MagDen Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The MagDen Fixture devices are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The MagDen Fixture devices are indicated for immediate loading when good primary stability is achieved.

The MagDen Dental Implant System offers MagDen Fixture, two abutment types (MagDen Mini Abutment, MagDen Abutment), MagDen Implant Healing Abutment, and MagDen Implant Cover Screw. The MagDen Fixture is made of Titanium alloy (ASTM F136, Ti-6A1-4V ELI) with S.L.A surface treatment. MagDen Mini Abutment and MagDen Abutment are made of Stainless Steel (SUS444) with TiN coating. MagDen Implant Healing Abutment and MagDen Implant Cover Screw are made of titanium alloy (ASTM F136, Ti-6A1-4V ELI) with no surface treatment. The system provides immediate masticatory function for partially and completely edentulous patients.

The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

Not Found

The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient s chewing function

The Luna Dental Implant System is a device of pure titanium(ASTM F67) and titanium alloy(ASTM F136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. The fixture's surface is S.L.A(Sand-Blasted, Large Grit, Acid-etched) Its materials, dimension, and intended use are similar to devices currently marketed worldwide. The Luna Dental Implant System fixture and healing abutment are supplied with gamma sterilization. Fixtures consisted of mount type and mount free type. Abutments consisted of simple abutment, hex and non-hex duo abutment, hex and non-hex angled abutment (15° & 25°), hex and non-hex contour abutment, hex and non-hex temporary abutment screw abutment with titanium cylinder, ball abutment with socket assembly, healing abutment, screw abutment screw, and abutment screw. Fixture dimension is 3.7mm x 8.5-15mm and 4.2mm - 5.7mm x 7.0mm - 15mm and Abutment diameter is 4.0mm ~ 6.0mm