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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 prosthesis for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated 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.

I'm sorry, but this document does not contain the information requested to describe the acceptance criteria and study proving device performance for a medical device. The document is a 510(k) summary for a dental implant system, primarily focusing on its substantial equivalence to predicate devices. It lists predicate devices, describes the device, and states its intended use, but it does not provide details on specific acceptance criteria for a study demonstrating performance, nor does it detail a study with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

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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 prosthesis for for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated 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 dental implant abutments, intended to demonstrate substantial equivalence to predicate devices already on the market. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document discusses:

• Predicate Devices: Lists specific 510(k) numbers for previously cleared dental implant systems.
• Device Description: Describes the endosseous implant system, focusing on pre-machined angulated abutments (15 and 25-degree) and wide-body abutments (4, 5, and 6 mm platform diameters).
• Intended Use: To facilitate the prosthetic phase and installation of a prosthesis for the patient.
• Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and service are similar to predicate devices. Materials used are ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. It also mentions compliance with GMP guidelines.

Therefore, I cannot provide the requested information about acceptance criteria or a study demonstrating device performance because it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail performance studies against specific acceptance criteria.

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Ask a specific question about this device