Search Results

FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.

FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.

The provided submission describes FotoDent® denture, a light-curing resin for 3D printing of full and partial dentures. This is a Class II device (21 CFR 872.3760).

1. Acceptance Criteria and Reported Device Performance

The device was tested against the applicable requirements of ISO 20795-1:2013 (Dentistry – Base polymers – Part 1: Denture base polymers) and ISO 7491:2000 (Dentistry – Dental materials – Determination of colour stability). The submission states that FotoDent® denture "met the applicable requirements" of these standards.

A direct comparison of physical properties between FotoDent® denture and the predicate device (DENTCA Denture Base II) is provided, which implicitly sets the acceptance criteria based on demonstrating "similar physical properties" to the predicate.

Note: The submission clarifies that "The differences in physical properties between FotoDent denture and the predicate device does not impact safety and effectiveness, as the finished clinical product is a custom-fitted denture base regardless of the material variation." This indicates that while some properties differ, they are deemed within an acceptable range for the intended use and do not negatively affect clinical outcomes compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The submission mentions "Bench test results" and "Non-Clinical Performance Testing" and "Biocompatibility" testing.

• Sample Size: The document does not specify the sample sizes used for these tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given these are bench tests and biocompatibility evaluations, they are inherently prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are non-clinical (bench tests and biocompatibility), and therefore do not involve human expert ground truth establishment in the way clinical studies with image interpretation or diagnosis would.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are non-clinical, and thus an adjudication method for human interpretation is irrelevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states under "Clinical Performance Data": "Not applicable. No human clinical testing was performed to support the substantial equivalence of FotoDent® denture."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. FotoDent® denture is a physical material (resin) for 3D printing, not an algorithm or a software device that would have standalone performance.

7. The Type of Ground Truth Used

For the non-clinical performance and biocompatibility testing, the "ground truth" is established by the specifications and standard methodologies outlined in the referenced ISO standards (ISO 20795-1:2013, ISO 7491:2000, ISO 10993-1:2009, ISO 7405:2008). These standards define the acceptable range or characteristics for the material properties.

8. The Sample Size for the Training Set

Not applicable. As FotoDent® denture is a physical material, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

Ask a specific question about this device