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The Atlantis Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the 3i Osseotite™ NT Certain™ (tapered wall) Implants with 4.0mm, 5.0mm and 6.0mm diameters.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Also, highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The Atlantis™ Abutments in Zirconia for 3i Certain Interface is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards (6972 & 13356). The abutment screw is made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Osseotite NT® Certain™ Implants (tapered wall) with 4.0 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) diameters.

The provided text focuses on regulatory approval (510(k) submission) for a dental abutment. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. However, it does not contain information about specific performance acceptance criteria or a study that directly proves the device meets those criteria, as typically found in a clinical or performance study report.

The document states the device "meets ISO Standards (6972 & 13356)" for its material (yttria-stabilized tetragonal zirconia polycrystals - Y-TZP) and its abutment screw material "Meets ASTM Standard F-136" (Titanium grade Ti-6A1-4V ELI). These are material specifications, not performance criteria for the assembled device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
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: No ground truth establishment/expert review is mentioned as part of a performance study.
4. Adjudication method for the test set: Not applicable as no performance test data is provided.
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 the device is a physical dental abutment, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance test data is provided.
8. The sample size for the training set: Not applicable as no AI/algorithm training is involved.
9. How the ground truth for the training set was established: Not applicable as no AI/algorithm training is involved.

The document is a regulatory submission demonstrating substantial equivalence, relying on the fact that the new device has similar materials, design, and intended use as devices already on the market, which are presumed to be safe and effective. It does not include a detailed performance study with acceptance criteria.

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