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The Straumann NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges.
The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.
Abutments are placed on dental implants to provide support for dental restorations. Temporary abutments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.

This is a medical device application for the Straumann NC Temporary Abutments. This submission focuses on establishing substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance evaluation against those criteria. Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

Here's why and what the text does provide:

• 510(k) Submissions: These submissions primarily aim to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and materials. It typically does not involve setting specific performance acceptance criteria for the new device as would be seen in a clinical trial designed to prove effectiveness or safety against predefined benchmarks.

The document states:

• "The proposed temporary abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices."

Therefore, I cannot populate the table or answer the specific questions you posed because the provided text does not contain the type of study data and acceptance criteria you are looking for. The focus of this document is on regulatory equivalence, not on a detailed performance study against a set of predefined acceptance criteria for a new device.

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Bone cutting instruments are intended for use during oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin or screw.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

The provided text is a 510(k) Summary for the Straumann Guided Instruments Drill Bits. It describes the device, its intended use, and its equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as it is a summary for a new version of an already-approved device, stating technological equivalence to a predicate device.

The 510(k) summary explicitly states:

• "The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices."
• "The intended use is identical to the predicate devices."
• "The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices."

Since this submission establishes substantial equivalence to a predicate device based on similar design, material, and intended use, a new clinical performance study with acceptance criteria, expert adjudication, or MRMC studies is typically not required or presented in a 510(k) summary for this type of device. The focus is on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the already cleared predicate.

Therefore, I cannot populate the requested table and answer the specific questions because the provided text does not contain the necessary information.

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Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Copings are intended to serve as a base for multi-unit bar or bridge restorations.

Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.

The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.

This 510(k) summary for the Straumann P.004 RC/NC Bar and Bridge Abutment Line does not contain the detailed information necessary to answer your questions about acceptance criteria and study design.

This document is a regulatory submission demonstrating substantial equivalence to previously cleared devices, not a detailed technical report of performance testing against specific acceptance criteria.

Here's why I cannot provide the requested information and what is available in the provided text:

What the document does state:

• Device Description: The Straumann P.004 Dental Implant System, including abutments, copings, and protective caps.
• Intended Use: For supporting prosthetic restorations (crowns, bridges, overdentures) in single or multiple tooth restorations, as bases for bar/bridge constructions, and for temporary restorations or soft tissue protection.
• Technological Characteristics: Claims substantial equivalence to predicate devices in material composition, basic design, and fundamental operating principles.
• Predicate Devices: A list of previously cleared Straumann devices to which equivalence is claimed.

Why the requested information is NOT in the document:

The provided text (a 510(k) summary) focuses on demonstrating "substantial equivalence" to existing, legally marketed devices. For this type of submission, the manufacturer typically highlights:

• Similarities in intended use.
• Similarities in technological characteristics (materials, design, operating principles).
• Performance data (if any significant differences exist or if new performance claims are made) is usually summarized or referenced, but the detailed study methodology, acceptance criteria, ground truth, and reader studies are rarely included in the brief summary itself. These details would be in a more comprehensive technical report or testing documentation (e.g., design control documents, test reports) that is part of the full 510(k) submission, but not typically released publicly in this summary format.

Therefore, I cannot populate the table or provide specific answers for most of your questions based solely on the provided text.

Here is a description of why each requested point cannot be answered from the provided text:

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

   • Cannot be provided. The document does not list any specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, dimensional accuracy) or the results from performance studies against such criteria. It generally states that the device has "the same material composition, basic design and fundamental operating principles" as predicate devices, implying performance is equivalent, but without specific metrics.

2. Sample size used for the test set and the data provenance:

   • Cannot be provided. No specific performance studies with test sets are described. The submission relies on equivalence to predicate devices rather than novel performance data requiring a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Cannot be provided. Since no specific test set or performance evaluation study (like a clinical study or even a detailed phantom study) is described in the summary, there's no mention of experts establishing ground truth.

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

   • Not applicable/Cannot be provided. No test set or expert evaluation process is described.

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:

   • Not applicable. This device is a mechanical dental implant component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

   • Not applicable. This is a physical medical device, not a standalone algorithm.

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

   • Not applicable/Cannot be provided. No ground truth is mentioned because no specific performance study requiring it is described in the summary.

8. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

   • Not applicable. As above, no training set for an algorithm is involved.

In summary, the provided 510(k) summary is a regulatory declaration of equivalence, not a detailed scientific paper describing performance studies and acceptance criteria. To get the information you're asking for, you would typically need to review the full technical documentation supporting the original 510(k) submission, which is generally not publicly available in this level of detail.

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The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.

Healing abutments, often referred to as healing caps, are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase.

P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.

P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.

The Straumann P.004 Dental Implant System is an integrated system of endosseous bone level dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.

The basal portion of the abutments has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized as requested:

Device: Straumann P.004 RC Temporary Abutments and P.004 Healing Abutments

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a study context. Instead, the submission focuses on establishing substantial equivalence to predicate devices based on intended use, materials, basic design, and fundamental operating principles.

Based on the available information, the implicit "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate devices and fulfilling the stated intended use without adverse events or deviations from established performance.

Therefore, a table would look like this, with the understanding that "reported performance" here refers to the rationale for substantial equivalence rather than explicit quantitative study results against pre-defined thresholds:

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

The provided text does not describe a "test set" in the context of a clinical performance study with human subjects or a statistical evaluation of device performance data. The submission is a 510(k) premarket notification for substantial equivalence, which primarily relies on comparing the new device to existing, legally marketed predicate devices.

There is no mention of a traditional "sample size" for a test set, nor any specific data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance evaluation. The "data" presented is largely a comparison of specifications and intended use against predicate devices.

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

This information is not applicable to this 510(k) submission as it focuses on demonstrating substantial equivalence rather than presenting clinical study data with ground truth established by experts. The "expertise" involved would be that of the manufacturer's engineers and regulatory affairs personnel in preparing the submission, and the FDA reviewers in evaluating it against regulatory requirements and established predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons stated above. There is no described "test set" and thus no need for an adjudication method.

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 information is not applicable. The device described (dental abutments) is a physical medical device, not an AI software intended to assist human readers (e.g., in medical imaging interpretation). Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable. As mentioned, the device is a physical dental abutment, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this 510(k) submission, the "ground truth" is established through regulatory precedent and technical specifications.

• Regulatory Precedent: The existence of already "legally marketed predicate devices" (Straumann P.004 Dental Implants, synOcta® Temporary Meso Abutment, P.004 RC Meso Abutment) serves as the primary ground truth. The new device is compared against these predicates to demonstrate it is "substantially equivalent" in terms of safety and effectiveness.
• Technical Specifications: The design, materials, and intended use of the new abutments are compared directly to those of the predicate devices. This involves engineering specifications and material data, validated against known safe and effective performance of the predicate.

There is no mention of clinical outcomes data, expert consensus on specific cases, or pathology reports used to establish ground truth for this particular submission.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.

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

This information is not applicable for the same reasons as above.

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