Search Results

Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z-Look3 Evo SLM is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). The Z-Look3 Evo SLM surface is grit blasted with medical grade Al20 and laser modified. Implants are available in three diameters (3.6, 4.0 and 5.0 mm) and four lengths (8, 10, 11.5 and13 mm). Z-Look3 Evo SLM implants are designed for single or multiple tooth restorations. Z-Look3 Evo SLM implants are a modification to Z-Look3 implants. The laser modified surface has been added to increase surface roughness and, therefore, the surface area available for contact with bone.

This document is a 510(k) summary for the Z-Look3 Evo SLM dental implant. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria and a device performance evaluation in the way requested.

Therefore, many of the requested sections regarding the study and acceptance criteria cannot be extracted from the provided text.

Here is what can be inferred:

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

This information is not explicitly provided in the document. The submission aims to establish substantial equivalence through design principles, materials, technological characteristics, and intended use, rather than reporting performance against specific, quantifiable acceptance criteria from a clinical study within this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The document does not describe a clinical study with a ground truth established by experts.

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

Not applicable. The document does not describe a clinical study.

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 is a medical device (dental implant) submission, not an AI/software device.

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

Not applicable. This is a medical device (dental implant) submission, not an AI/software device.

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

Not applicable. The document does not describe a clinical study with a ground truth.

8. The sample size for the training set

Not applicable. The document does not describe a clinical study with a training set.

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

Not applicable. The document does not describe a clinical study with a training set.

Summary of available information from the document related to device characteristics:

• Intended Use: Implantation into the upper and lower jaw for attachment of prosthodontic appliances to replace missing teeth. Also suitable for patients with metal allergies.
• Device Description: One-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). Surface is grit blasted with medical grade Al2O3 and laser modified.
• Dimensions: Available in three diameters (3.6, 4.0, 5.0 mm) and four lengths (8, 10, 11.5, 13 mm).
• Equivalence Basis: Substantial equivalence to predicate devices (Z-Look3 Dental Implant System, Nobel Biocare Zirconia Implant, Oral Iceberg S.L. CeraRoot Implant System, Contour Healer Temporary Abutment, Zimmer Dental Inc. Plastic Temporary Abutment) based on:
  • Same intended use.
  • Similar design principles.
  • Same operating principle.
  • Same basic design.
  • Same or very similar materials.
  • Similar physical dimensions.
  • Similar packaging and sterilization methods.
  • Differences in technological characteristics (laser modified surface) do not raise new safety/efficacy issues.

Ask a specific question about this device