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Nobel Biocare's NobelPerfect Conical Connection Hexagonal implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelPerfect Conical Connection Hexagonal implants are indicated for single or multiple unit restorations. The NobelPerfect Conical Connection Hexagonal implants can be used in splinted or non-splinted applications. The NobelPerfect Conical Connection Hexagonal implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelPerfect Conical Connection Hexagonal implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelPerfect Conical Connection Hexagonal implants are similar in design to the implants cleared under NobelPerfect, Conical Connection, K062936. The predicate internal square was changed to internal hexagonal connection.

The provided text is a 510(k) summary for the NobelPerfect Conical Connection Hexagonal dental implant. This document is a regulatory submission to the FDA, primarily focused on demonstrating substantial equivalence to a predicate device. It certifies that the device meets the regulatory requirements for safety and effectiveness through equivalence to an already approved device. Therefore, it does not contain a study that demonstrates the device meets specific acceptance criteria in the way a clinical performance study would for a novel device.

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not provide a table of acceptance criteria or reported device performance in the context of a standalone clinical study. The device's "performance" is implicitly deemed acceptable by its substantial equivalence to the predicate device, NobelPerfect Conical Connection (K062936).

• 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. There is no test set or related data described from a clinical study for this device. The submission relies on demonstrating equivalence in design and materials to a previously cleared device.

• 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. No test set requiring expert ground truth establishment is described.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.

• 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 document pertains to a dental implant, not an AI software or imaging device that would typically undergo MRMC studies.

• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth, in the context of a clinical study or AI performance evaluation, is not relevant to this 510(k) submission which relies on substantial equivalence.

• 8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is a physical dental implant and not an AI/machine learning model.

• 9. How the ground truth for the training set was established: Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary of the Device and Submission:

The NobelPerfect Conical Connection Hexagonal implant is a screw-shaped dental implant intended to support prosthetic devices. The 510(k) submission establishes its substantial equivalence to the legally marketed device, NobelPerfect Conical Connection (K062936). The primary change in the new device is the internal connection from a square to a hexagonal design. Regulatory clearance is based on the premise that this design change does not raise new questions of safety or effectiveness, as the overall intended use and fundamental technological characteristics remain comparable to the predicate device. Therefore, the "acceptance criteria" were met by demonstrating this substantial equivalence through comparison to the predicate, rather than through a new, independent clinical performance study.

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