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

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Medentika Abutment System is an abutment system including ten abutment designs compatible with eleven currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21 °

The provided text is a 510(k) summary for the Medentika Abutment System, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The context of this type of document is a regulatory submission, not a study evaluating AI performance or a diagnostic device. Therefore, the questions related to AI, ground truth establishment, expert consensus, sample sizes for AI training/testing, adjudication methods, and MRMC studies are not applicable to the information contained in this document. The document describes a "substantial equivalence" claim for a physical medical device (dental abutments), meaning it demonstrates the device is as safe and effective as a legally marketed device.

Here's the information that can be extracted or inferred based on the provided text, with responses to your questions where applicable and an explanation when not applicable:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it refers to regulatory compliance and equivalence to predicate devices. The "reported device performance" is demonstrated through various non-clinical tests designed to show the physical and mechanical properties are comparable to existing, legally marketed devices.

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

This information is not provided in the document. The document refers to "non-clinical testing data" for sterilization, biocompatibility, engineering, dimensional, and static/dynamic compression-bending tests. These types of tests typically involve a sample of units for each test, but the specific number of units is not detailed in this summary. The data provenance is also not specified, though the manufacturer (Medentika GmbH) is based in Germany. The tests are prospective in nature, as they involve testing the actual device components.

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 question is not applicable. This document describes a medical device approval based on physical properties and comparison to predicate devices, not an AI or diagnostic study requiring expert ground truth for a test set.

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

This question is not applicable. There is no "test set" in the context of expert review or diagnostic assessment for this type of device approval.

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 question is not applicable. This is a physical medical device (dental abutment), not an AI-assisted diagnostic or imaging system.

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

This question is not applicable. This is a physical medical device, not an algorithm.

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

This question is not applicable in the context of expert-determined ground truth for a diagnostic task. For this device, the "ground truth" equivalent would be established by:

• Established ISO standards: For sterilization (ISO 17665-1, ISO 17665-2), biocompatibility (ISO 10993-5), and mechanical fatigue (ISO 14801). Compliance with these standards is considered the "truth" for safety and performance in their respective domains.
• Performance of predicate devices: The "truth" is that the predicate devices are legally marketed and considered safe and effective. The subject device demonstrates comparable performance to these established devices.

8. The sample size for the training set

This question is not applicable. This document describes the approval of a physical medical device, not an AI algorithm requiring a training set.

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

This question is not applicable. There is no "training set" in the context of AI for this device approval.

Ask a specific question about this device