Search Results

Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant in an implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.

Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory component designed to adapt a smaller platform abutment to a larger platform endosseous implant to a within the implant/abutment system. The NOBELREPLACE® Adapter provides a gradual transition from abutment to implant, and can only be used as part of the implant/abutment system, not on its own. It is designed to remain a component of the implant/abutment system for as long as the implant remains in the patient's mouth.

The provided text describes a 510(k) submission for the NOBELREPLACE® Adapter, a dental device. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trials. The document primarily focuses on establishing substantial equivalence to predicate devices based on design and intended use.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance: No performance data is presented.
2. Sample size used for the test set and data provenance: No test set or study is described.
3. Number of experts used to establish ground truth and their qualifications: No ground truth establishment is mentioned.
4. Adjudication method: Not applicable as no study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a physical dental device, not an AI algorithm.
7. Type of ground truth used: Not applicable as no study data is presented.
8. Sample size for the training set: Not applicable as this is not a machine learning device.
9. How ground truth for the training set was established: Not applicable.

The document states that the NOBELREPLACE® Adapter is a hollow titanium alloy device used to adapt a smaller platform abutment to a larger platform endosseous implant. The 510(k) submission focuses on comparing its attributes and intended use to existing legally marketed devices (Replace Scalloped Margin Implant System and Nobel Biocare Permanent Centric Post) to demonstrate substantial equivalence, rather than presenting results from a performance study against acceptance criteria.

Ask a specific question about this device

Nobel Biocare's Procera® Abutment Brånemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the Brånemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants:

• 3i® 3.75
• Lifecore® Biomedical Restore 3.75
• Zimmer® Dental Taperlock 4.0
• Sterngold Implamed® 3.75

The Procera® Abutment Brânemark is an artificial tooth abutment designed to fit and function on root-form endosseous implants having an external hexagon abutment interface.
Nobel Biocare's Procera® Abutment Brånemark is intended for use in the treatment of partially edentulous patients in arder to restore chewing function. The Procera® Abutment Brånemark is a prosthetic device panonto in brace's Brånemark external hexagon endosseous implant as well as the endosseous implants specifically indicated. The device has been developed for long-term, permanent use.
Nobel Biocare's Procera® Abutment Brånemark can be made from titanium, alumina, or zirconia.

The provided text is a 510(k) summary for the Nobel Biocare Procera® Abutment Brånemark. It details the device description, indications for use, and a statement that "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Class II Special Controls Guidance Document: Root Porn Lindoseous Beach (May 12, 2004) was identified as applicable to this submission."

However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document is a regulatory submission for a dental implant abutment, focused on demonstrating substantial equivalence to previously marketed devices. It does not include the type of performance study details requested in your prompt.

Ask a specific question about this device

Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 45°. When used with angulations between 30° and 45°, the following applies:

• the tilted implants must be splinted
• a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch

Nobel Biocare Endosseous Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients.

Nobel Biocare Endosseous Implants are machined from titanium and available straight or tapered. The implants are either a) coated with hydroxyapatite powder, i.e. HA coated implants; b) have a surface treatment of the implant that consists of a titanium oxide layer, i.e. TiUnite implants; or c) do not have any coating or surface treatment, i.e. Branemark implants.

Nobel Biocare Endosseous Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion. Nobel Biocare Endosseous Implants can be placed anywhere in the upper or lower jaw where good initial stability of the implant can be obtained.

This document is a 510(k) summary for Nobel Biocare Endosseous Implants. It does not contain any information regarding acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on comparing the new device's design, materials, and intended use to an existing predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information (points 1-9) from this document.

Ask a specific question about this device

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients.

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD Implant is intended for placement in the interforaminal area of the anterior mandible for the fully edentulous lower arch.

Nobel Biocare's NobelDirect™ OD Implant is a threaded one-piece root form endossions with an integrated ball attachment designed for one-stage surgical procedures and overdenture restorations. The integratou ball attablimont as intended to provide immediate retention for removable tissue supported lower overdentures in fully edentulous jaws.

Nobel Biocare's NobelDirect™ OD Implant can be placed in an edentulous arch or piaced simultaneously Nobel Diocare 3 Nobel Biocare's Nobel Biocare's NobelDirect™ OD Implant in immediate function applications, it is essential to obtain primary implant stability. Nobel Biocare's Gold Cap for Ball Attachment is to be utilized with the NobelDirect™ OD Implant.

Nobel Biocare's NobelDirect™ OD Implant is machined from titanium and is available with a straight or tapered contour. The NobelDirect™ OD Implant has a surface treatment that consists of a titanium oxide layer (TiUnite) that extends over the implant threads and onto the implant collar.

This 510(k) premarket notification is for a dental implant, the NobelDirect™ OD Implant. The provided document does not contain information regarding specific acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement. This type of information is typically found in performance testing sections of a 510(k) submission, which are not present in this excerpt.

The document primarily focuses on:

• Device Description: What the NobelDirect™ OD implant is (threaded one-piece root form endosseous implant with an integrated ball attachment).
• Intended Use: For one-stage surgical procedures and overdenture restorations, providing immediate retention for removable tissue-supported lower overdentures in fully edentulous jaws.
• Indications for Use: Specifically stated as "a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients." The "Indications for Use" form also specifies "immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD implant is indicated for use in the interforaminal area of the anterior mandible for the fully edentulous lower arch."
• Substantial Equivalence: Listing legally marketed predicate devices (Brånemark System Implants K022562 and Replace One-Piece Implants K023952) to establish substantial equivalence.
• FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text.

Ask a specific question about this device

NobelRondo Dental Ceramic Alumina is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from alumina.

NobelRondo Dental Ceramic – Alumina is dental porcelain intended for use in the construction of aluminum oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides.

The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added.

The NobelRondo Dental Ceramic – Alumina is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.

This document is a 510(k) Summary of Safety and Effectiveness for the NobelRondo Dental Ceramic – Alumina, a dental porcelain. It does not present any data relating to artificial intelligence (AI) or machine learning (ML) device performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device that uses AI.

The document discusses the physical properties and intended use of a dental ceramic material and its substantial equivalence to a legally marketed predicate device (Procera® All-Ceramic Dental Porcelain). The FDA's review in this case is focused on the material's safety and effectiveness for its stated dental applications, not on the performance of a diagnostic or assistive AI system.

Ask a specific question about this device

Nobel Biocare's Procera® Abutment Octagon is indicated for the treatment of partially edentulous patients requiring prosthetic devices that fit Straumann regular neck 4.8mm endosseous implants in order to restore chewing function.

The Procera® Abutment Octagon is an artificial tooth abutment designed to fit and function on the Straumann Dental Implant System regular neck 4.8mm endosseous implant.

Nobel Biocare's Procera® Abutment Octagon is intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Procera® Abutment Octagon is a prosthetic device that fits only the Straumann regular neck 4.8mm endosseous implant. The device has been developed for long-term, permanent use.

Nobel Biocare's Procera® Abutment Octagon can be made from either titanium or zirconia.

Here's an analysis based on the provided document, addressing your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for the Procera® Abutment Octagon. For devices approved via the 510(k) pathway, the primary "acceptance criterion" from a regulatory perspective is Substantial Equivalence to a legally marketed predicate device. This means the new device is as safe and effective as a legally marketed device that is not subject to PMA.

The document does not outline specific, quantitative performance acceptance criteria (e.g., strength thresholds, fatigue limits) for the Procera® Abutment Octagon, nor does it present detailed study results with numerical performance metrics against such criteria. This is typical for a 510(k) summary, which focuses on demonstrating equivalence rather than establishing new performance benchmarks.

Instead, the study mentioned (though not explicitly detailed) would have aimed to demonstrate that the new device performs equivalently to the identified predicate devices in its intended use.

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

The document does not specify the sample size used for any test set or the data's provenance (e.g., country of origin, retrospective or prospective). This level of detail is typically found in the full 510(k) submission, not the summary document.

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

The document does not specify the involvement of experts for establishing ground truth for a test set. In the context of dental implants, performance testing often involves mechanical and biocompatibility evaluations rather than interpretation by human experts.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set. This is not applicable given the type of device and the information provided.

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

A MRMC comparative effectiveness study was not done or mentioned. This type of study is typically relevant for interpretative devices (e.g., AI for medical imaging), not for a physical device like a dental abutment. The effectiveness of the abutment would be assessed through mechanical testing and clinical use (post-market surveillance).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical dental abutment, not an algorithm or AI system.

7. The Type of Ground Truth Used

For this type of physical device, "ground truth" would typically be established by:

• Engineering specifications and test standards: Conformance to recognized standards for mechanical strength, fatigue, material properties (e.g., ISO standards for dental implants and components).
• Biocompatibility testing: In vitro and in vivo studies to ensure the materials are safe for use in the human body.
• Clinical performance (implicitly via predicates): The understanding that the predicate devices have a history of safe and effective use provides a baseline for the "ground truth" of performance.

The document does not explicitly state a specific "ground truth" type but implies adherence to safety and effectiveness demonstrated by predicate devices and relevant standards.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical dental abutment, not an AI/ML algorithm that requires a training set.

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

This question is not applicable as the device is a physical dental abutment, not an AI/ML algorithm.

Ask a specific question about this device

The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.

The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

Nobel Biocare's Permanent Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.

The Nobel Biocare Permanent Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.

This document is a 510(k) summary for the Nobel Biocare Permanent Centric Post, a dental device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it describes the device, its indications for use, and its substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission, not a scientific study report.

Ask a specific question about this device

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center an abutment and as a seal to prohibit fluids from seeping into the implant interior.

The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

The Nobel Biocare Centric Post is a support component indicated for use as an alignment post to center a temporary abutment and act as a seal to prohibit fluids from seeping into the implant interior during temporization.

The Nobel Biocare Centric Post is a component within the implant system, which is intended for use in restoring the chewing function of fully edentulous and/or partially edentulous patients.

Nobel Biocare's Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.

The Nobel Biocare Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.

These attributes of the Nobel Biocare Centric Post enhance the performance of the implant/abutment system, such as the Nobel Perfect Implant System, and make the component desirable for use in fabricating both final restorations and temporary restorations.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Nobel Biocare Centric Post. This type of regulatory submission in the US is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with defined performance metrics as in a de novo or PMA submission for novel devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets these criteria in the context of device performance, as it is focused on demonstrating substantial equivalence. It does not include:

1. A table of acceptance criteria and the reported device performance: This document focuses on demonstrating that the Nobel Biocare Centric Post is substantially equivalent to existing legally marketed devices (Replace® Scalloped Margin Implant System and Nobel Perfect Implant System) based on its design, intended use, and materials, rather than presenting a performance study against predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: No performance testing data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth or expert evaluation is mentioned for performance assessment.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily describes the device, its indications for use, and identifies predicate devices for the purpose of demonstrating substantial equivalence for 510(k) clearance.

Ask a specific question about this device

The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Nobel Biocare's Nobel Direct is a name change of the legally marketed device "Replace" One Piece Implant" (K023952).

Nobel Biocare's Nobel Direct utilizes the same material and fundamental design as the unmodified, predicate device, "Replace" One Piece Implant" (K023952).

Nobel Biocare's Nobel Direct incorporates a design modification by adding an endosseous implant with a diameter of 3.0mm to the existing diameter sizes already in the Nobel Direct product line.

The Nobel Direct 3.0mm implant is restricted for use only in the maxillary lateral position or the mandibular central and lateral incisor position. The Nobel Direct 3.0mm implant/abutment is only available in lengths of 13mm and 15mm. The implant represent the portion of the unit placed in the bone (i.e. threaded portion).

This document is a 510(k) premarket notification for a dental implant, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document states that the Nobel Direct device is a name change of a legally marketed device and incorporates a design modification by adding a 3.0mm diameter implant to the product line. The review emphasizes its substantial equivalence to a predicate device (K023952) rather than providing new performance data based on a clinical study for the modified device.

Specifically, the requested information elements are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria for performance benchmarks, nor does it present a table of reported device performance metrics from a study.
2. Sample sized used for the test set and the data provenance: No test set or sample size for a performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there is no test set, there is no mention of experts establishing ground truth for it.
4. Adjudication method for the test set: Not applicable as there is no described test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical dental implant, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance study is described.
8. The sample size for the training set: Not applicable as this document describes a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document's primary purpose is to demonstrate substantial equivalence to a previously approved device, not to present new performance data from a clinical trial for the modified device.

Ask a specific question about this device

The indications for use for the Nobel Perfect Implant System are the unmodified device, Replace Scalloped Margin Implant System. It is a system with a scalloped coronal implant designed for single stage or two stage surgical procedures. The Nobel Perfect Implant System is intended for use to restore chewing function in edentulous and/or partially edentulous patients.

The Nobel Perfect Implant System is a name change of the legally marketed device Replace Scalloped Margin Implant System. The Nobel Perfect Implant System utilizes the same components (i.e. implant, abutment, etc.) as the predicate device, Replace Scalloped Margin Implant System (K021584), yet contains three design modifications.

First, the screw-retained healing cap is now designed as a shorter, cover plug. The design modification was developed in order to attain a better seal and reduce the overall height of the implant by lowering its profile.

Second, a silicone o-ring has been added to the implant system. The o-ring is intended to be placed between the implant and the healing abutment in order to prevent fluids and tissue from seeping between the two parts during the healing process.

Third, changes in materials have been specified. The material used to manufacture the former screw-relained healing cap was acetal (Delrin). The cover plug and the o-ring will be made from a medical grade translucent silicone. The material used for the manufacture of the healing abutment has changed from acetal (Delrin) to polysulfone so that it may be radiation sterilized.

This device (K030257) is a dental implant system. The provided text indicates this is a "Special 510(k) Notification" for a name change and minor design modifications to a legally marketed predicate device (Replace Scalloped Margin Implant System, K021584).

A Special 510(k) pathway is used when a modification to a legally marketed device does not alter the device's fundamental scientific technology or its indications for use. For such submissions, the FDA typically relies on a comparison to the predicate device and does not require new clinical studies to demonstrate safety and effectiveness, as the modifications are deemed minor.

Therefore, the provided document does not describe a study that establishes acceptance criteria for new device performance, nor does it contain data from a study undertaken to prove those criteria are met for this specific device (Nobel Perfect Implant System).

Instead, the submission essentially states that because the Nobel Perfect Implant System is substantially equivalent to its predicate device (with only minor modifications that do not impact the fundamental performance or indications), it meets the same implicit acceptance criteria for safety and effectiveness as the predicate.

Here's why the requested information cannot be extracted from this document:

• No new performance data presented: Special 510(k)s focus on demonstrating that modifications do not negatively impact safety and effectiveness or change the intended use, rather than presenting new performance data against specific criteria.
• Reliance on predicate: The core of a Special 510(k) is the assertion that the modified device is as safe and effective as the predicate.

Given this, I cannot fill out the requested table or answer most of the specific questions as there is no new performance study data included in this 510(k) summary for the Nobel Perfect Implant System.

If this were a traditional Premarket Notification (510(k)) requiring new performance data, the information would typically be presented in sections like "Performance Data," "Bench Testing," "Biocompatibility," "Clinical Data," etc. Such sections are absent here because it is a Special 510(k).

Ask a specific question about this device