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The Implant-One™ Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for prosthetic rehabilitation of the mandible or maxilla with a multi-unit restoration.

The subject devices comprise abutments designed for the 300, 400, and 500 Series of the Implant-One™ system. All subject device abutments incorporate a Morse taper at the implant/abutment interface, have a hexagonal male end for alignment purposes and are screw retained. The series is grouped according to the implant/abutment interface size and each series is color coded for ease of identification. The subject devices are Angled Multi-Unit Abutments.

The Implant-One Multi-Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. The Implant-One Multi-Use Abutments are indicated for multiple-tooth restorations.

Angled Multi-Unit Abutments are available for the 300, 400, and 500 series and used for multiple implant restorations such as screw retained dentures. These abutments are offered in cuff heights of 2.5 mm and 3.5 mm for all series.

The provided text K212394 is a 510(k) premarket notification for an dental implant abutment. The document describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data.

From the text, there is no information provided regarding acceptance criteria for a study proving device performance in a clinical setting, nor any details of a study involving human subjects or AI algorithms. The submission explicitly states: "No clinical data were used in support of this submission."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document does not contain this information.

Specifically, the following points of your request cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: No such clinical performance study or its acceptance criteria are mentioned. The "performance data" section refers to mechanical testing (ISO 14801), sterilization (ISO 17665), biocompatibility (leveraged from K173701), and MRI review (scientific evidence/published literature). These are non-clinical and do not involve "reported device performance" in a clinical sense.
2. Sample sizes used for the test set and the data provenance: Not applicable as no clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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, as there is no mention of AI assistance or human reader studies.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for the reasons mentioned above. For the non-clinical tests, the "ground truth" would be the standard test methods (e.g., ISO standards), but this is not clinical ground truth.
8. The sample size for the training set: Not applicable as this is not an AI/ML clinical study.
9. How the ground truth for the training set was established: Not applicable.

The submission focuses on demonstrating substantial equivalence based on non-clinical performance data (mechanical, sterilization, biocompatibility, MRI safety) and comparison of indications for use and technological characteristics with predicate devices.

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