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The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.

The abutment submitted is for use in multiple unit, partial, or full edentulous case types. The underlying surface mates with the external hex of the dental implant, and the set screw down the middle locks it into place. Its purpose is to provide a gentle contain of more ing from the top of the implant into the oral cavity, ending with a metal margin or a cosmetic margin that can be established at the laboratory phase. The laboratory technician with this abutment has coping devices to place over the abutment or the abutment analog to fabricate the prosthetic design in the laboratory, which will then be brought to the patient for these clinical indications. It is not intended for single-tooth application, as there is no built-in, anti-rotational features. It is, therefore, recommended only as a multiple unit; partially edentulous; or a multiple unit, totally edentulous abutment design. It functions similarly to other designs in this implant system for similar indications. The components are made of biocompatible ASTM standard titanium/titanium alloy, and it is not considered an implant, as is an abutment piece placed above the top of the implants.

I am sorry, but the provided text is a letter about a 510(k) clearance for a dental abutment and does not contain information about acceptance criteria or a study proving its performance. The document focuses on regulatory approval rather than technical performance data. Therefore, I cannot extract the requested information.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the proBthetic phase and installation of the programs of the program and 824 U.S. Highway 1, Suite 370 1499 W. Palmetto Park Road Boca Raton 33486-3311 N. Palm Beach, Florida 33408 (407) 392-4747 (407) 627-5560 FAX (407) 392-8320 FAX (407) 627-4214 "Tomorrow's Technology Today"

Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for an endosseous implant system, specifically focusing on wide body and pre-angled abutments. It primarily establishes substantial equivalence to predicate devices and does not describe a clinical study or performance testing against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

• None stated: The document does not define specific quantitative acceptance criteria or report on device performance against such metrics. Its focus is on demonstrating substantial equivalence to predicate devices.

Study Details

As no specific study is described in this 510(k) summary, the following information is not available:

1. Sample size used for the test set and the data provenance: Not applicable.
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 for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: 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: Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Information that is available in the document:

• Device Description:
  • Consists of implants, tools, and pre-machined angulated abutments (15 and 25-degree).
  • Includes wide-body abutments of one and two-piece prosthetic designs with 4, 5, and 6 mm platform diameters.
  • Placed on top of implant fixtures after integration.
• Intended Use:
  • Similar to other implant systems.
  • To facilitate the prosthetic phase and installation of prostheses.
• Technology Characteristic Summary:
  • Material, manufacturing process, gamma sterilization, design, geometry, and services are similar to predicate devices.
  • Materials: ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5.
  • GMP guidelines are in place and have been inspected by the FDA Office of Compliance.
• Predicate Devices:
  • General: Dental Imaging Associates (K902433, K902434, K902435), Implant Innovations (K932123).
  • For Wide Body: Nobelpharma (K925766, K934826, K934495), Implant Innovations (K933969, K934126, K933462).

In summary, this document serves as a regulatory submission demonstrating substantial equivalence through comparison to existing devices, rather than presenting data from a clinical performance study with predefined acceptance criteria.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the programs and institute Moza Suite 302 for the patient.

Endosseous implant system tools and consists of implants, This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document does not contain information about acceptance criteria or a study proving a device meets those criteria. The provided text is a 510(k) summary for dental implant components (abutments), focusing on demonstrating substantial equivalence to predicate devices. It describes the device, its intended use, and technological characteristics.

Therefore, I cannot provide the requested table or answer the questions related to study design, sample sizes, ground truth establishment, or expert involvement.

Ask a specific question about this device

The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the proBthetic phase and installation of the progressions who works we 302 for the patient .

Endosseous implant system consists of implants. tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of specific metrics like sensitivity, specificity, or any numerical performance targets.

Here's a breakdown of why I cannot fulfill your request with the given input:

• No Acceptance Criteria: The document describes the device, its intended use, and its similarities to predicate devices, but it does not specify any quantitative acceptance criteria (e.g., "device must achieve X% accuracy").
• No Study Details for Performance: The text mentions "substantial equivalence" to predicate devices, but this refers to the regulatory pathway for market clearance, not a performance study with a test set, ground truth, or statistical analysis. It states that the "CDRH, as well as the Office of Compliance have received a substantial equivalence letter," indicating a regulatory review, not a clinical or technical performance study in the way typically required for AI/diagnostic devices.
• No "Reported Device Performance": Since no acceptance criteria or performance study is detailed, there's no reported numerical performance to include in a table.
• No Details on Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, or Training Set: All these elements are crucial for describing a performance study, and they are entirely absent from the provided text. The document focuses on regulatory equivalence and device description.

Therefore, I cannot generate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or study types because the necessary information is not present in the provided 510(k) summary. This document is focused on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than on providing detailed performance metrics from a dedicated study.

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