Search Results

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.

Ask a specific question about this device

The NB 1 SA 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. NB 1 SA 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 NB 1 SA Implant System is composed of ARUM NB 1 SA Fixture, ARUM NB Cover Screw, ARUM NB Healing Abutment, ARUM Cemented Abutment (Hex, Non-Hex), and Abutment screw. ARUM NB 1 SA Fixture is a thread type implant body made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The surface of the fixture is treated with SLA (Sandblasted with Large grit and Acid-etching). The fixture is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity and it is connected with dental prostheses.

The document provided is a 510(k) Premarket Notification for the NB 1 SA Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data, rather than reporting on a specific study that evaluates device performance against acceptance criteria in a clinical setting.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not present in this document. The information provided heavily relies on non-clinical tests to support the substantial equivalence claim.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are largely linked to meeting the requirements of specific ISO and ASTM standards for non-clinical testing. The "reported device performance" is that the results of these tests "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document. The testing described is primarily non-clinical (sterilization, shelf-life, biocompatibility, LAL endotoxin, material characteristics).
• Data Provenance: Not explicitly stated as "country of origin for data." The submitter is Arumdentistry Co., Ltd. from Daejeon, Republic of Korea. The testing itself is non-clinical and conducted in vitro or ex vivo (e.g., material testing, microbial inactivation). The document does not describe human subject data.
• Retrospective or Prospective: Not applicable as the described tests are non-clinical hardware tests.

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. The ground truth for the non-clinical tests is established by the specified international standards and guidelines (e.g., ISO, ASTM, AAMI/ANSI). No human expert "ground truth" derived from clinical data is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The described tests are non-clinical and do not involve adjudication by experts in the context of diagnostic interpretation.

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

No MRMC comparative effectiveness study is mentioned. The device is an endosseous dental implant system, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable to the device described. The NB 1 SA Implant System is a physical dental implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced international standards (e.g., SAL of 10^-6 for sterility, specific material properties, successful validation of sterilization cycles, biocompatibility under ISO guidelines, etc.). No clinical ground truth (like pathology or outcomes data) is discussed for this 510(k).

8. The sample size for the training set

Not applicable. This document describes non-clinical testing of a physical medical device, not a machine learning algorithm that requires training data.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned or relevant to the device described.

Ask a specific question about this device

DESS Dental Smart Solutions abutments 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 custom abutments for use with Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to implement a labeling change for certain Pre-milled Blanks of the DESS Dental Smart Solutions abutment system, cleared under K170588, K173908 and K191986, to permit the manufacture of custom abutments with angulation up to 30° and to add three (3) Pre-milled Blanks that also will include such labeling. Design parameters cleared in K170588. K173908 and K191986 were limited to straight abutments only. This change in labeling is for Pre-milled Blanks compatible with three (3) systems: NobelParallel Conical Connection, Straumann Bone Level, and Zimmer Screw-Vent/Tapered Screw-Vent implants. Note that, because NobelActive and Nobel Parallel Conical Connection share the same implant/abutment interface, they are considered one system for purposes of this submission, as they were in K170588, K173908 and K191986. No new compatibilities are added in this submission.

Pre-milled Blanks are designed for fabrication of a custom abutment by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. Nobelcompatible Pre-milled Blanks are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELL (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) or from cobalt chromium alloy (Co-Cr-Mo) conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539. Straumann-compatible and Zimmercompatible Pre-milled Blanks are made of titanium alloy (Ti-6Al-4V). They are available in engaging designs and are compatible with the implant systems shown the table below Compatible Implant Systems and Platforms. Except for the maximum angulation of the final abutment and the addition of three (3) Pre-milled Blanks of 14 mm diameter to the previously cleared Pre-milled Blanks of 10 mm and 14 mm diameter, subject device Pre-milled Blanks are identical to Pre-milled Blanks cleared (with slight variations on the name) in K170588, K173908 and K191986. Compatibility with the implant platform was demonstrated in K170588 and K191986.

The design parameters for the CAD/CAM fabrication of custom abutments from subject device Premilled Blanks are:

Minimum wall thickness - 0.45 mm Minimum post height – 4.0 mm
Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Maximum angulation of the final abutment - 30°

Manufacture of CAD/CAM custom abutments from Pre-milled Blanks is to be performed at a Terrats Medical validated milling center.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DESS Dental Smart Solutions, formatted as requested.

The provided document is a 510(k) summary for a medical device (DESS Dental Smart Solutions). It focuses on demonstrating substantial equivalence to previously cleared devices, particularly for a labeling change allowing custom abutments with angulation up to 30 degrees.

It's important to note that this document does not describe a study that proves the device meets acceptance criteria in the way a clinical trial or a detailed performance study report would. Instead, it leverages prior clearances and non-clinical testing to argue for substantial equivalence.

The acceptance criteria provided here are implied by the comparison to predicate devices and the non-clinical testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for an existing device with a labeling change, the "acceptance criteria" are more about demonstrating equivalence and safety/performance as established by the predicate device and relevant standards. The "reported device performance" refers to the results that support this equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a "test set" in the context of a dataset of patient images or outcomes. The performance data primarily refers to non-clinical testing (e.g., mechanical tests on physical samples).
  • For the ISO 14801 dynamic fatigue testing, the number of physical samples tested is not explicitly stated in this summary. It would typically be a pre-defined number per test arm as per the standard to achieve statistical significance for the specific test.
• Data Provenance: The data provenance mentioned is related to:
  • Prior clearances (K170588 and K173908): This refers to previously submitted and cleared devices, implying existing data on biocompatibility and other baseline characteristics. This is a form of retrospective leveraging of previously reviewed data.
  • Non-clinical lab testing (ISO 14801): This testing would have been conducted in a laboratory setting, specific to the device design for this submission. The origin (country/lab) of this specific testing isn't mentioned in the summary, but it would be part of the full submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes non-clinical performance data and substantial equivalence to predicate devices, not a study involving human expert interpretation of data or images. The "ground truth" here is established by engineering standards (e.g., ISO 14801) and material specifications (e.g., ASTM standards).

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. There is no human interpretation or adjudication described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical data and substantial equivalence arguments for a physical dental device, not an AI or imaging-related device requiring human reader performance evaluation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical dental abutment, not an algorithm or software. "Standalone performance" in this context refers to the device's mechanical and material performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device, in terms of its safety and effectiveness, is established by:

• Engineering Standards: Specifically, ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) for mechanical performance.
• Material Standards: ASTM F136 and ASTM F1537 for material biocompatibility and mechanical properties.
• Predicate Device Performance: The underlying ground truth is based on the previously established safety and effectiveness of the legally marketed predicate devices, which this new device is deemed substantially equivalent to. This is a regulatory "ground truth" rather than a clinical or pathological one.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical dental abutment, not a machine learning model. There is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device