Search Results

The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• Astra Tech Implant System® Multi Base Abutment EV, 4.8 mm, max 30°
• DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
• 3i OSSEOTITE®
• Astra Tech OsseoSpeed™
• Neodent Grand Morse
• NobelReplace® Conical
• NobelReplace® Trilobe
• Nobel Brånemark System®
• Straumann BLX Implants
• DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°
• NobelActive® NobelParallel Conical
• Straumann® Bone Level
• Zimmer Screw Vent® and Tapered Screw-Vent®
• Dentium SuperLine® Abutments, 4.5-5.5 mm, max 30°
• Keystone Multi Unit Abutment, 4.8 mm, 0°
• Implant Direct GPS® Angled Abutment, 5.0 mm, max 30°
• MIS Multi-unit Abutments, 4.8 mm
• C1 Conical Connection Implant System, max 30°
• V3 Conical Connection Implant System, max 30°
• Internal Hex Implant System, max 30°
• Conical Connection, max 30°
• Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• Nobel Biocare Brånemark Multi-Unit Abutment, 4.8 mm, max 17°
• Nobel Biocare Multi-Unit Abutment Plus, 4.8 mm, max 30°
• Nobel Biocare Multi-Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare Multi-Unit Abutments for Straumann and Astra Tech System, 4.8mm, max 30°
• Nobel Biocare Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• Paltop Multi Unit Abutment, 5.0 mm, max 17°
• Southern Compact Conical Abutments, 4.8 mm
• MAX Implant System, 0°
• Provata Implant System, max 30°
• Deep Conical (DC) Implants, 0°
• Piccolo Implants, 0°
• External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar

Ask a specific question about this device

Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or mandbular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment. The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Alpha Dent Implants Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system. Abutments are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage surgical operation for all implants type beside the INTEGRAL which is for one stage only. The system includes two-piece implant families: Active, Active Plus, and Classic, and a one-piece implant family: Integral. The system also includes prosthetic components such as healing caps, straight and angular abutments, titanium esthetic abutments, multi-unit abutments, ball attachments, and accessories.

The Alpha Dent Implants Dental Implants System has been assessed for acceptance criteria through a series of non-clinical tests.

1. Acceptance Criteria and Reported Device Performance

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

The provided document does not specify exact sample sizes for each of the non-clinical tests (biocompatibility, surface analysis, sterilization validation, pyrogenicity, shelf life, and fatigue testing). It generally refers to "test articles" being used. The data provenance is derived from non-clinical laboratory studies conducted by the manufacturer and an independent testing laboratory. The country of origin of the data is not explicitly stated, but the standards cited are international (ISO, ASTM, ANSI/AAMI).

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 acceptance criteria and study detailed are based on objective non-clinical performance data and adherence to specified international standards, rather than expert judgment or interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This section is not applicable as the acceptance criteria are based on objective measurements and adherence to pre-defined technical standards, not on subjective assessment or adjudication by multiple evaluators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a non-clinical evaluation focusing on the physical and mechanical properties of the dental implant system.

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

This section is not applicable as the device is a dental implant system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established through:

• International Standards: Adherence to specific requirements outlined in standards like ASTM F 136 (material), ISO 10993-5 (biocompatibility), ANSI/AAMI/ISO 11137-1, EN ISO 11137-2 (sterilization), USP , (pyrogenicity), ASTM-F-1980, ISO 11607-1 (shelf life), and ISO 14801:07 (fatigue testing).
• Predicate Device Equivalence: Performance was compared to legally marketed predicate devices, demonstrating "substantial equivalence" in terms of design, materials, and performance characteristics.
• Objective Measurements: Laboratory measurements such as microscopy for surface morphology (SEM), elemental analysis (EDS), and force/cycle counts for fatigue testing.

8. The Sample Size for the Training Set

This section is not applicable as the device is a dental implant system, not an AI algorithm that requires a training set.

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

This section is not applicable for the same reason as above.

Ask a specific question about this device

MIS V3 Conical Connection 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, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The MIS V3 Conical Connection implants are manufactured from titanium (Ti-6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The cylinder screw type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. They have an internal conical connection with an anti-rotation index of six directions for Standard Platform Implants and three directions for Narrow Platform Implants. The implants are self-tapping, root-form with tapered threads. They feature a tri-surface crestal contact, built-in platform switching and a flat apex enabling grip into bone. The MIS V3 Conical Connection Implants are provided in 3.3, 3.9, 4.3 and 5.0 mm diameters and with the following lengths: 3.3 mm diameter: 10mm, 11.5mm, 13mm and 16mm; 3. 9mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 4.3mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm; 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants surface is sand blasted and acid etched. The MIS V3 Conical Connection Dental Implant System is to be used in combination with a wide range of abutments provided in order to aid in the prosthetic rehabilitation. For a quick identification of the diameters and to ensure the adequate abutments (cover screws, healing caps, cement- retained abutments, gold abutments, OT-Equators & ball attachments, Multi unit abutments and Temporary Ti and Peek Abutments), the internal part of the implant is anodized for coloring purposes as follows: "Narrow Platform" (NP) – 3.3mm diameter: blue; "Standard Platform"(SP) - 3.9mm, 4.3mm and 5.0 diameters: purple. The MIS V3 Conical Connection Implant package comes with a sterile, single-use final drill (packaged in a sterile pouch). Components: The MIS V3 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants.

The provided text describes a 510(k) premarket notification for a dental implant system (MIS V3 Conical Connection Dental Implant System) and focuses on demonstrating substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria based on a clinical study of its performance. The document primarily details mechanical and material equivalency, as well as biocompatibility and sterilization, as opposed to performance metrics that would typically arise from an AI/ML-based medical device.

Therefore, many of the requested items (acceptance criteria table, sample size for test set, expert involvement, adjudication, MRMC study, standalone performance, ground truth types, training set details) are not applicable to this document as it pertains to a physical dental implant, not an AI/ML device requiring such performance studies.

However, I can extract and present the acceptance criteria for mechanical performance and the study that proves the device meets those from the document, as it is a physical device and not an AI/ML algorithm.

Here's the information that can be extracted relevant to the device's mechanical and material acceptance:

Acceptance Criteria and Device Performance for MIS V3 Conical Connection Dental Implant System

The "acceptance criteria" for this dental implant system are implicitly defined by proving its substantial equivalence to legally marketed predicate devices, particularly regarding mechanical performance and material properties. The primary study proving this is Fatigue Testing per ISO 14801:2007, which is a standard for dental implants.

1. Table of Acceptance Criteria (Implicit from Predicate Equivalence) and Reported Device Performance:

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

• Test Set (for Fatigue Testing): The specific number of implants/abutments used in the fatigue test is not explicitly stated as a "sample size" in the document, but it's implied that sufficient samples were tested to demonstrate compliance with ISO 14801:2007.
• Data Provenance: The tests were conducted internally by MIS Implants Technologies Ltd. and by an "independent testing laboratory" for shelf-life testing. The country of origin for the data is not explicitly stated beyond Israel (MIS Implants Technologies Ltd. is based in Israel) for the company and general international standards for the testing. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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

• N/A. This information is relevant for studies involving human interpretation or clinical outcomes for AI/ML devices. For a physical device demonstrating mechanical and material properties, "ground truth" is established by adherence to recognized international standards (e.g., ISO for mechanical testing, AAMI/ISO for sterilization), and expert judgment is inherent in the development and validation of these standards, not typically in individual "readers" of test results.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods (like 2+1, 3+1) are primarily used in clinical studies or expert review processes for AI/ML performance evaluation. For mechanical and sterilization testing, the "adjudication" is the pass/fail result based on the quantitative measurements against the standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is specific to evaluating the clinical effectiveness of a diagnostic tool (often imagery-based) with and without AI assistance, involving multiple human readers. This document is for a physical dental implant.

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

• No. This question applies to AI/ML algorithms. The performance assessment here is for the physical device itself (mechanical, material properties).

7. The Type of Ground Truth Used:

• For mechanical and physical properties (fatigue, material composition, sterility, shelf-life), the "ground truth" is adherence to established international standards and engineering specifications (e.g., ISO 14801:2007, ASTM F136-13, ANSI/AAMI/ISO 11137-1:06, EN ISO 11137-2:12, ISO 17665-1:2006, ISO 14971). Pathological or outcomes data (clinical ground truth) was not required for this 510(k) as per section 9.

8. The Sample Size for the Training Set:

• N/A. This term is relevant for AI/ML models. This is a physical device.

9. How the Ground Truth for the Training Set was Established:

• N/A. This term is relevant for AI/ML models.

Ask a specific question about this device

CAMLOG® Vario SR components for crown and bridge restorations:

• Occlusal screw-retained crown, bridge and bar constructions on CAMLOG® implants (with J and K article numbers) in the anterior and posterior region of the maxilla and mandible
  CAMLOG® Vario SR components for bar restorations:
• Anchorage of implant-supported full dentures for the edentulous maxilla and mandible in combination with 2, 4 or more CAMLOG® implants (with J and K article numbers)

CAMLOG® Vario SR Abutments are titanium dental implant abutments for use with the CAMLOG® Dental Implant System. They have an internal connection to the implant, a conical interface with the prosthetic attachment, and are used for single and multi-unit screw-retained, prefabricated restorations. They are appropriate for supporting laboratory cast frameworks as well as laser-welded bar constructions and have dedicated prosthetic components.

The provided text describes the 510(k) summary for Altatec GmbH CAMLOG® Vario SR Abutments. This is a medical device submission, and the information requested pertains to the evaluation of AI/ML-driven medical devices. Unfortunately, the provided document does not contain any information about an AI/ML-driven device or its performance evaluation.

Instead, the document details a traditional medical device (dental implant abutments) and its substantial equivalence to other legally marketed predicate devices. The "testing" mentioned refers to mechanical testing according to ISO 14801 for static and dynamic fatigue properties of the physical device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies involving sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the content provided.

I can, however, extract the relevant "testing" information for this specific device from the provided text, which focuses on mechanical performance:

Acceptance Criteria and Device Performance (for mechanical properties of the physical device):

Regarding the other requested information (AI/ML specific details):

1. Sample size used for the test set and the data provenance: Not applicable as the device is not AI/ML-driven.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be its physical strength and material properties.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device