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The SD TL 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. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

SD TL Implant System consist of below: Fixture - SD Tissue Level Fixture - SD Bone Level Fixture Abutment - Multi Angled Cylinder - Multi Digital Cylinder - Multi Ti Cylinder - Multi Healing Cap - Healing Abutment - Temporary Abutment 1) Fixture This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function, the product is used as a substructure implanted into the human body. An endosseous dental implant is a device made of a material as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with non-submerged external connection and with submerged internal connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The dimension ranges of the subject device are below: 1. SD Tissue Level Fixture: Ø 3.7, 4.2, 4.6, 5.0 (D) x 7.0, 8.5, 10.0, 11.5, 13.0 mm (L) 2. SD Bone Level Fixture: Ø 6.48 (D) x 7.0, 8.5, 10.0, 11.5 mm (L) 2) Abutment The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Angled cylinders come in engaging and non-engaging types. 1. Multi Angled Cylinder: Ø 5.5 (D) x 9.5, 10.5 mm 2. Multi Digital Cylinder: Ø 5.5 (D) x 6.5, 7.5, 8.5, 9.5 mm 3. Multi Ti Cylinder: Ø 4.8 (D) x 4.5 mm, Ø 5.5 (D) x 8.0, 9.0 mm 4. Multi Healing Cap: Ø 4.8, 5.7 (D) x 4.35, 5.85, 7.35 mm 5. Healing Abutment: Ø 3.5, 3.67, 4.2, 5.2, 6.2, 7.5, 8.5 (D) x 6.9 ~ 13.3mm 6. Temporary Abutment: Ø 3.7, 4.0 (D) x 10.4, 10.45, 12.4, 12.45 mm Tolerance of dimension shall be within ± 1% range. Multi Digital Cylinder and Multi Ti Cylinder are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment. The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction. For the Multi Digital Cylinder and Multi Ti Cylinder the design parameters for the CAD/CAM zirconia superstructure are: - Minimum wall thickness – 0.5 mm; - Minimum post height for single-unit restorations – 4.5 mm; - Maximum gingival height – 5.0 mm; - Minimum gingival height – 0.5 mm; - Angulation - 0° *The post height is defined as measured above the gingival height of the final patient-matched design. The digital workflow requires the use of the following equipment: - Restorative Material: Non-Sterile Zirconia Block (K190112) - Dental Cement: U-Cem Premium & MAZIC Cem (K193260) The SD TL Implant System is compatible with the SD Bone Level Fixtures and NB Implant Systems. (as the below table).

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.

Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) used to produce dental restoration to support designing computer for dental use and to process cutting as a manufacture unit, on which CAD/CAM system is applied for processing and sintering. After application, this material cannot to be reused for fabrication.

The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.

SD Implant System consist of below: Fixture - SD Bone Level Fixture Abutment - Cover Screw - Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment - Angled Abutment - Master Fix - Master Fix Screw - Digital Abutment - Temporary Abutment - Multi Abutment - Multi Angled Abutment - Abutment Screw - Multi Scan Healing Cap - Multi Scan Healing Cap Screw - Multi Master Fix - Multi Master Fix Screw - Multi Ti Cylinder - Multi Digital Cylinder - Multi Temporary Cylinder SD Implant System is consisted with Fixtures (SD Bone Level Fixture) and Abutments (Cover Screw, Healing Abutment, Scan Healing Abutment, Cemented Abutment, Master Fix, Digital Abutment, Temporary Abutment, Multi Abutment, Multi Angled Abutment, Multi Scan Healing Cap, Multi Master Fix, Multi Ti Cylinder, Multi Digital Cylinder, Multi Temporary Cylinder) This product is a dental implant which is placed into alveolar bone to replace the function of missing teeth. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA (Sandblasted with Large-grit and Acid-etching). As a dental implant which is placed into alveolar bone to support dental prostheses such as artificial teeth used to rehabilitate a patient's masticatory function. An endosseous dental implant is a device made of a material Pure titanium (Conforming to ASTM F67) which will be placed in the alveclar bone to replace the function of missing tooth. The SD Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The subject device abutments are not compatible with 3.8mm diameter implant bodies cleared in K213506 and K230725, nor with 3.2mm diameter implant bodies cleared in K240091. SD Implant System Abutment is compatible with the SD Implant Fixture and Some of the SD Implant System connections are compatible with NB 1 Compatible with SA Implant System, NB Implant System and NB Mini Implant System. (Cleared K213506, K230725, K240091) SD Implant System Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures, Separate sets of abutments are presented for compatibility with each Fixture. Dental Abutments are similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics. The Multi Abutments and Multi Angled Abutments intended to be placed onto osseointegrated dental implants to provide support for prosthetic superstructures at the gingival level. Multi Abutments are available as straight abutments, which have an integrated thread and can be placed directly onto the implant. Multi Angled Abutments are angled abutments, which can be attached to the implant with the corresponding abutment screw. The multi-unit abutments are intended for multi-unit restoration only. The Cover Screw, Healing Abutment, Scan Healing Abutment, Scan Healing Abutment Screw, Multi Scan Healing Cap and Multi Scan Healing Cap Screw are provided sterile by the manufacturer. All other abutments are provided non-sterile and should be sterilized by the end user before use. The multi-unit abutments included in this system are specifically intended to be used solely for multiunit restorations. The SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are composed of two-piece abutment that is a titanium base at the bottom and zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction. All digitally designed custom abutments for use with SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinder are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. SD Master Fix, multi Master Fix, Digital abutments, and multi Digital cylinderare intended for single-unit or multi-unit restorations. For the Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations (length above the abutment collar / gingival height) – 4.5 mm; Maximum gingival height - 5.0 mm; Minimum gingival height - 1.5 mm; Angulation - 0° and All zirconia superstructures are for straight abutments only. The Master Fix, Multi Master Fix, Digital Abutment, Multi Digital Cylinder are used as part of a twopiece abutment, where the base is premanufactured from titanium alloy (Ti-6AI-4V Eli) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment. The SD Implant System is intended for single use only. The Abutments are made of Ti-6AI-4V Eli (Conforming to ASTM F136) The SD Implant System connections compatible with NB 1 SA Implant System, NB Implant System and NB Mini Implant System

The SD TL 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. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed Pre-Milled Abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

An endosseous dental implant is a device made of a material such as Pure Titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The SD TL Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with non-submerged external connection. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The SD TL Implants are available with a gingival height of 1.5 mm. The abutment is made of Ti-6Al-4V Eli (Conforming to ASTM F136) to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screw-and cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The Multi Pre-Milled cylinders come in engaging and non-engaging types. All designed abutments are sent to an ARUM DENTISTRY validated milling center. The diameters of Multi Pre-Milled Cylinder are 4.8 mm Square.

The Customized Abutments are intended use for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screw-retained single restorations or cement- retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw. Patient-Specific Abutment is compatible with following Implant System: 1. Neodent Implant System -GM Line / Implant Diameter (mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0/ Restorative Platform Diameter: 3.0 2. BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7 3. Astra Tech Implant System / Implant Diameter (mm): 3.5, 4.0, 4.5, 5.0/ Restorative Platform Diameter: 3.5, 4.0, 4.5, 5.0 4. 3i OSSEOTITE® Certain® Dental Implants / Implant Diameter (mm): 4.1, 5.0, 6.0/ Restorative Platform Diameter: 4.1, 5.0, 6.0 All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific abutment are 3.5, 3.75, 3.8, 4.0, 4.3, 4.5, 4.6, 5.0, 6.0 mm and Hex connection design. Customized abutments are supplied with an abutment and provided non-sterile.

The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

The C&B NFH Hybrid is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physicalchemical, mechanical and biocompatible properties.

The Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally-designed Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

The Ti-Base & Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment. Device Components: 1) Abutment - Ti-Base - Master Fix - Abutment Screw The Ti-Base and Master Fix are provided non-sterilized. Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

The Customized Abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Customized Abutments are indicated for screwretained single restorations or cement-retained single or multi-unit restorations. The Customized Abutment will be attached to a dental implant using the included abutment screw. Patient-Specific Abutment is compatible with following Implant Systems: 1. Zimmer Tapered Screw-Vent® / Implant diameter size (mm): 3.7, 4.1, 4.7, 6.0/ Restorative Platform diameter (mm): 3.5, 4.5, 5.7 2. Straumann® Bone Level Tapered Implant / Implant diameter size (mm): 3.3, 4.1, 4.8/ Restorative Platform diameter (mm): 3.1, 3.7, 4.4 All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

Patient-specific abutment is made from Ti-6Al-4V Eli conforming to ASTM F136 to be used in fabricating patient-specific abutments. The subject devices are indicated for cemented or screwand cement retained prosthesis (SCRP) restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific abutment are 3.3, 3.7, 4.1, 4.7, 4.8, 6.0 mm and Hex and square connection design. Customized abutments are supplied with an abutment screw and provided non-sterile.

The NB Mini Implant System is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The NB Mini Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NB Mini Implant System consist of below: Fixture - NB Fixture Mini Abutment - Cover Screw - . Healing Abutment - Scan Healing Abutment - Scan Healing Abutment Screw - Cemented Abutment Mini - . Angled Abutment Mini - Abutment Screw The NB Fixture Mini is made of Ti-6AI-4V Eli (Conforming to ASTM F136) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Mini Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and morse taper bevel. The surface of the fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures.

The Angled Abutment is made from Ti-6Al-4V Eli (conforming to ASTM F136). Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crown, bridges, or over-dentures. The Angled Abutment has two types of connection (HEX and Non-HEX). The Angled Abutment connections compatible with NB 1 SA Implant System and NB Implant System. The Angled Abutment surfaces are partially TiN coated. Angled Abutments are supplied with an abutment screw previous cleared device as K213506. The dimension ranges of the subject device are below: No. | Device Name | Dimension ---|---|--- 1 | Angled Abutment | Ø 4.5, 5.5 (D) x 8 mm (Post Height) x 17° 2 | Abutment Screw (Cleared in K213506) | Ø 2.35 (D) x 8.4 mm (L) Angled Abutment and Abutment Screw (Cleared in K213506) are provided non-sterile. The abutment should be sterilized before use by end user sterilization. These devices are intended for single use only. The Angled Abutment is compatible with the following implant systems. Manufacturer | 510(k) No. | Implant system compatibility | Dimension ---|---|---|--- ARUM DENTISTRY Co., Ltd. | K213506 | NB 1 SA Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 ARUM DENTISTRY Co., Ltd. | K230725 | NB Implant System | Ø 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5