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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).

The provided FDA 510(k) Clearance Letter for the "SD TL Implant System" does not contain information about acceptance criteria or a study proving the device meets those criteria in the context typically seen for Artificial Intelligence (AI) or software as a medical device (SaMD) products.

This document is for a physical medical device (dental implants and associated components), specifically an endosseous dental implant (Product Code: DZE, NHA; Regulation Number: 21 CFR 872.3640; Regulatory Class: Class II).

The "performance data" section in this document describes:

• Biocompatibility testing (ISO 10993-5, ISO 10993-12) to ensure the materials are safe for use in the human body.
• Sterilization validation (ISO 11137-1, 11137-2, ANSI/AAMI ST79, ISO 17665-1, -2, ISO 11737-1,-2, ISO 11138-1, AAMI / ANSI ST72:2011/(R)2016) to ensure the device is sterile.
• Shelf-life testing (ASTM F1980) to confirm stability over time.
• Mechanical performance testing (ISO 14801) for static compression and compression fatigue, which are standard tests for the structural integrity of dental implants.
• Scanning electron microscopy (SEM) and Energy dispersive X-ray spectroscopy (EDS) for surface characteristics.
• MR environment condition review to assess safety in MRI environments.

These tests are standard for a physical implantable device to demonstrate substantial equivalence to a predicate device. They are not related to AI/software performance criteria (like accuracy, sensitivity, specificity, AUC) or human reader study designs (like MRMC studies, ground truth establishment by experts, adjudication methods).

Therefore, I cannot populate the requested table or answer the questions related to AI/software performance, ground truth, expert consensus, or MRMC studies, as this information is not present in the provided document.

The document explicitly states: "Non-clinical testing data submitted, referenced or relied on in this submission support demonstrating substantial equivalence." and "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate." This refers to the physical and material properties, not AI algorithm performance.

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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 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.

There were no acceptance criteria or studies on device performance to meet stated acceptance criteria discussed in the provided text. The text describes a 510(k) premarket notification for the "SD TL Implant System," which is a dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, intended use, and non-clinical performance testing (biocompatibility, sterilization, shelf-life, and mechanical testing).

The document states that biocompatibility, sterilization, shelf-life, and mechanical performance testing (according to ISO 14801 for static compression and compression fatigue) were conducted. It concludes that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate." However, specific acceptance criteria values for these tests and the detailed results of how the device met them are not provided in the document.

Therefore, for the requested information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document generally states that tests met "the criteria of the standards" but does not enumerate these criteria or specific performance values.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document mentions mechanical testing according to ISO 14801 but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this device certification is for a dental implant system based on non-clinical performance, not an AI/diagnostic device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. For this dental implant, "ground truth" would be the established performance standards (e.g., ISO manufacturing standards, material properties, mechanical strength benchmarks) against which the device's physical properties and performance are measured.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

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