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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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