Search Results
Found 4 results
510(k) Data Aggregation
(354 days)
Customized Abutment and Screw is used as a complement component for dental implants placed in the jawbone after tooth loss, to connect, support and retain the restoration or implant superstructure. Customized Abutment and Screw is indicated for single unit restorations.
Customized Abutment and Screw is compatible with following Implant Systems:
| No. | Implant System Compatibility | Implant Body Diameter(mm) | Platform Diameter(mm) |
|---|---|---|---|
| 1 | Straumann Bone Level RC 4.1, RC 4.8 (composed of pure titanium) | 4.1,4.8 | 4.1,4.8 |
| 2 | Straumann Bone Level NC 3.3 (composed of pure titanium) | 3.3 | 3.3 |
| 3 | Nobel Biocare Active NP3.5 | 3.5 | 3.5 |
| 4 | Nobel Biocare Active RP4.3/5.0 | 4.3, 5.0 | 3.9, 3.9 |
All digitally designed abutments for use with Customized Abutment and Screw are intended to be manufactured at a BESMILE validated milling center.
The Customized Abutment and Screw is composed of two parts: the customized abutment and screw. Among them, the customized abutment is machined from Ti-6Al-4V titanium alloy material in accordance with ASTM F1472, and the screw is machined from Ti-6Al-4V ELI titanium alloy material in accordance with ASTM F136. And the surface of product is not modified. The lower part of the product has a fixed interface shape, and the upper part is machined according to the needs of the patient. In the process of dental implant surgery, as the upper structure of the implant, it is installed on the implant platform anchored in the bone, which plays the role of supporting, retaining and stabilizing the prosthesis.
Customized Abutment and Screw is created via use of the Pre-milled Blank.
The information of the Implant Systems compatible with the product is detailed in Table 1.
N/A
Ask a specific question about this device
(117 days)
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:
- 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
- BioHorizons Tapered Internal Implant System / Implant Diameter (mm): 3.8, 4.6, 5.8/ Restorative Platform Diameter: 3.5, 4.5, 5.7
- 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
- 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.
This document is a 510(k) Premarket Notification from ARUM DENTISTRY Co., Ltd. for a dental device called "Customized Abutment." This notification aims to demonstrate the substantial equivalence of their device to legally marketed predicate devices, as required by the U.S. Food and Drug Administration (FDA).
Based on the provided information, the 510(k) summary (pages 4-12) details the device, its intended use, materials, and substantial equivalence comparison to a predicate device. The information is focused on a medical device clearance and does not describe an AI/ML-driven medical device, nor does it contain information typically associated with studies proving device performance against acceptance criteria in the context of AI/ML.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, because the provided document does not pertain to an AI/ML device.
The document describes a physical medical device (Customized Abutment for dental implants) and its non-clinical testing to demonstrate substantial equivalence, primarily through:
- Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
- Static and fatigue testing according to ISO 14801.
The closest information provided to "acceptance criteria" relates to the design parameters of the abutment, such as post height, angle, wall thickness, diameter, and gingival height, which are likely evaluated against engineering specifications and performance standards like ISO 14801.
Ask a specific question about this device
(134 days)
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:
- 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 - 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 provided text describes the regulatory clearance (K234112) for the ARUM DENTISTRY Co., Ltd. Customized Abutment, particularly focusing on its substantial equivalence to a predicate device (K223634). The information provided does not outline acceptance criteria for an AI/ML powered device, nor does it detail a study proving the device meets AI/ML specific acceptance criteria.
The information provided pertains to a traditional medical device (dental abutments) and focuses on engineering and material performance rather than AI/ML algorithm performance.
Therefore, many of the requested fields regarding AI/ML specific criteria cannot be extracted from the given text.
However, I can provide information on the non-clinical tests conducted for the Customized Abutment device, which are analogous to acceptance criteria and performance data for this type of medical device.
1. Table of Acceptance Criteria and the Reported Device Performance (Non-AI/ML):
| Non-Clinical Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility | Demonstrated by the reference ARUM DENTISTRY submission, K223634, using Ti-6Al-4V Eli conforming to ASTM F136 and the same materials and manufacturing processes. Implied to meet ISO 10993-5 and ANSI/AAMI ST72. |
| Sterilization Validation | The Customized Abutment is delivered non-sterile for end-user sterilization. The recommended sterilization has been validated according to ISO 17655-1 and applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015." The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. |
| MRI Safety | Non-clinical worst-case MRI Review was performed. Evaluation was based on scientific rationale and published literature, considering the entire system (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. |
| Mechanical Performance (Static and Fatigue) | Demonstrated through static and fatigue testing according to ISO 14801. (Specific numerical results are not provided in the text, but the successful completion of these tests indicates meeting performance requirements for the device type.) |
| Compatibility with Implant Systems | Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was performed to confirm compatibility with listed implant systems (Zimmer Tapered Screw-Vent® and Straumann® Bone Level Tapered Implant). |
| Manufacturing Process Control | All digitally-designed Customized abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture. This implies adherence to established quality control for manufacturing precision. |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing (Static and Fatigue): The document mentions "The worst-case construct was tested" for sterilization and that "static and fatigue testing according to ISO 14801" was conducted. Specific sample sizes are not provided.
- Data Provenance: The non-clinical tests were conducted internally or by contractors to ARUM DENTISTRY. The document does not specify a country of origin for the data beyond ARUM DENTISTRY Co., Ltd. being in the Republic of Korea. These are most likely prospective tests conducted specifically for this submission.
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):
This information is not applicable and not provided as the approval is for a physical dental abutment, not an AI/ML algorithm requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. "Adjudication" typically refers to resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.
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:
This is not applicable. No MRMC study was conducted as the device is a physical dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical product, not an algorithm.
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 standards and specifications used (e.g., ASTM F136 for material, ISO 14801 for mechanical testing, ISO 17655-1 for sterilization, FDA guidance for MRI safety). The device's performance is compared against the requirements of these established standards.
8. The sample size for the training set:
This is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The device design parameters are "trained" through engineering design principles and verified through physical testing.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set as it's not an AI/ML algorithm. The design of the abutment relies on established engineering principles, material science, and compatibility specifications with existing implant systems.
Ask a specific question about this device
(144 days)
ARUM Dentistry's Customized Abutments are intended 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 ARUM Dentistry prosthetic screw.
Customized Abutments are compatible with the implant systems listed in the Compatibility Table:
| Implant Platformcompatibility | Restorative Platformdiameter (mm) | Implant Body diameter (mm) |
|---|---|---|
| NB 1 SA ImplantSystem | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | 3.8, 4.0, 4.15, 4.25, 4.5, 5.0 |
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 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 mm and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems:
| Proprietary Name | NB 1 SA Implant System |
|---|---|
| Compatible Implants (K number) | K222131 |
| Implant diameter size | 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 |
| Implant Interface Connection Type/Size (mm) | Internal Connection type/2.5 |
| Type of Implant-Abutment Connection | Hex/Non-Hex |
Patient-specific abutments are supplied with an abutment screw previous cleared device as K222131 and 7 newly designed screws and provided non-sterile.
| Parameter | Min (mm) | 10 Ø Max (mm) | 14 Ø Max (mm) |
|---|---|---|---|
| Total Height | 6.0 | 16.0 | 16.0 |
| Post Height for Single-Unit Restoration | 4.0 | 13.0 | 13.0 |
| Angle | 0° | 30° | 30° |
| Wall Thickness | 0.5 | 3.8 | 6.0 |
| Diameter | Based on minimumwall thickness | 9.9 | 13.9 |
| Gingival Height | 0.5 | 4.0 | 4.0 |
Patient-specific abutment design parameters:
The provided text describes the 510(k) submission for ARUM DENTISTRY Co., Ltd.'s "Customized Abutment." This is a Class II medical device (dental implant abutment). The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for FDA clearance.
Here's a breakdown of the requested information, based on the provided text. It's important to note that many of the typical "acceptance criteria" and "study proves that the device meets the acceptance criteria" details for AI/ML devices, such as those related to accuracy, sensitivity, specificity, or reader studies, are not applicable to this type of device. This is a physical, custom-fabricated medical device (dental abutment), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the "acceptance criteria" here refer to performance testing (mechanical, biocompatibility, sterilization) to ensure the device is safe and effective and substantially equivalent to a predicate. The study that proves it meets criteria is the testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards/Tests) | Reported Device Performance (Summary) |
|---|---|---|
| Material | Ti-6Al-4V Eli conforming to ASTM F136 | Device fabricated from Ti-6Al-4V Eli conforming to ASTM F136. |
| Sterilization | ISO 17665-1, ISO 17665-2, and ISO 14937 | Sterilization validation performed for predicate and leveraged. Device is provided non-sterile (steam sterilization by user). |
| Biocompatibility | ISO 10993-5 and ANSI/AAMI ST72 | Biocompatibility testing performed for predicate and leveraged. |
| Mechanical Performance | ISO 14801 (Static and Fatigue Testing) | Worst-case constructs subjected to static compression and compression fatigue testing. Results met the criteria of the standard, demonstrating substantial equivalence. |
| MRI Environment Safety | Scientifically reviewed (published literature, FDA Guidance) for magnetically induced displacement force and torque | Non-clinical worst-case MRI review performed using scientific rationale and published literature. Rationale addressed parameters per the FDA Guidance, concluding safety. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a numerical "sample size" in terms of number of abutments tested for mechanical performance. It refers to "worst-case constructs" for each compatible implant line. This is typical for mechanical testing where a representative "worst-case" configuration is tested to demonstrate the device's limits.
- Data Provenance: The testing data is derived from non-clinical performance tests (mechanical testing, sterilization validation, biocompatibility) of the device and its predicate. The origin of the raw data (e.g., specific lab, country) is not detailed, but it is implied to be internal or from a contract testing lab as part of the manufacturer's quality system. It is prospective for the specific tests performed to support this submission.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of medical device submission. Ground truth (in the AI/ML sense) is not established by human experts for mechanical/biocompatibility testing. The "ground truth" for proving the device meets acceptance criteria relies on the results of standardized engineering and biological tests conducted according to recognized standards (e.g., ISO, ASTM).
4. Adjudication method for the test set
- Not applicable. There is no human adjudication process involved in interpreting the results of mechanical, biocompatibility, or sterilization tests for this device. The results are compared directly to pre-defined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This is a physical, custom-fabricated dental device, so such a study is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm. Performance evaluation for this device is based on physical and material properties, not algorithmic output.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by objective, standardized test methods (e.g., stress-strain measurements for mechanical testing, biological assays for biocompatibility, sterility indicator results for sterilization). It is based on engineering and scientific standards rather than expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML or software device that undergoes "training." Its design and manufacturing are based on established engineering principles for dental abutments.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this type of device. The "ground truth" for its development and validation relies on adherence to design specifications, material standards, and validated manufacturing processes.
Ask a specific question about this device
Page 1 of 1