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The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Nobel Biocare's Nobel Direct is a name change of the legally marketed device "Replace" One Piece Implant" (K023952).

Nobel Biocare's Nobel Direct utilizes the same material and fundamental design as the unmodified, predicate device, "Replace" One Piece Implant" (K023952).

Nobel Biocare's Nobel Direct incorporates a design modification by adding an endosseous implant with a diameter of 3.0mm to the existing diameter sizes already in the Nobel Direct product line.

The Nobel Direct 3.0mm implant is restricted for use only in the maxillary lateral position or the mandibular central and lateral incisor position. The Nobel Direct 3.0mm implant/abutment is only available in lengths of 13mm and 15mm. The implant represent the portion of the unit placed in the bone (i.e. threaded portion).

This document is a 510(k) premarket notification for a dental implant, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document states that the Nobel Direct device is a name change of a legally marketed device and incorporates a design modification by adding a 3.0mm diameter implant to the product line. The review emphasizes its substantial equivalence to a predicate device (K023952) rather than providing new performance data based on a clinical study for the modified device.

Specifically, the requested information elements are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific acceptance criteria for performance benchmarks, nor does it present a table of reported device performance metrics from a study.
2. Sample sized used for the test set and the data provenance: No test set or sample size for a performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there is no test set, there is no mention of experts establishing ground truth for it.
4. Adjudication method for the test set: Not applicable as there is no described test set.
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 this is a physical dental implant, not an algorithm.
7. The type of ground truth used: Not applicable, as no performance study is described.
8. The sample size for the training set: Not applicable as this document describes a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document's primary purpose is to demonstrate substantial equivalence to a previously approved device, not to present new performance data from a clinical trial for the modified device.

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