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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The purpose of this submission is to expand the Neodent Implant System components cleared under K101207, which included dental implants with an external hex abutment interface. The external hex additions include Titamax Smart EX, and Drive Smart implants that are provided with a new implant mount that can be used as a temporary abutment. Additional straight, angled and ball-type abutments with external hex interfaces are also included in this submission.

All of the subject device external implants are threaded, self-tapping, root form, endosseous dental implants with a grit blasted and acid etched endosseous surface. All implants have a smooth machined collar on the transgingival surface. The Titamax Smart implants are provided in five endosseous thread diameters (3.3, 3.75, 4.0, 4.5, 5.0 mm), three platform diameters (3.3, 4.1, 5.0 mm), and five overall lengths (9, 11, 13, 15, 17 mm). The Titamax Smart EX implants are provided in two endosseous thread diameters (3.75, 4.0 mm), one platform diameter (4.1 mm), and six overall lengths (9, 11, 13, 15, 17, 19 mm). The Drive Smart implants are provided in three endosseous thread diameters (3.5, 4.3, 5.0 mm), three platform diameters (3.3, 4.3, 5.0 mm), and five overall lengths (8, 10, 11.5, 13, 16 mm). All implants are made from commercially pure titanium conforming to ASTM F67.

This submission includes the following abutments: the Smart Mount in three platform diameters (3.3, 4.1/4.3, 5.0 mm); Conical Abutments (platform diameter 3.3 mm); Angled Mini Conical abutments angled 17° or 30°, in four platform diameters (3.3, 4.1, 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; SF Universal Post abutments (platform diameter 4.5 mm); Angled Post abutments angled 17° or 30° in four platform diameters (3.3. 4.1. 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; and Equator Attachments for overdentures or partial dentures in three platform diameters (4.1, 4.3, 5.0 mm) and gingival heights from 2 mm to 5 mm. All abutments are made from titanium alloy conforming to ASTM F136.

The Neodent Implant System is a dental implant system designed to support prosthetic devices like artificial teeth to restore chewing function.

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

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in the provided text. The submission refers to "non-clinical data" for testing.
• Data Provenance: The document does not specify the country of origin for the non-clinical data. It is a retrospective comparison to previously cleared predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence relied on engineering and material characteristic comparisons, not expert interpretation of clinical data or images.

4. Adjudication method for the test set

Not applicable. This was a non-clinical equivalence study, not a clinical trial requiring adjudication of patient outcomes or expert diagnoses.

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 submission is for a physical medical device (dental implants and abutments), not an AI-powered diagnostic or assistive tool.

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-based device.

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

The ground truth used for demonstrating substantial equivalence was based on engineering standards, material specifications, and physical performance testing (e.g., fatigue testing according to ISO 14801), comparing the subject device's attributes to those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. There is no training set for this device.

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