(259 days)
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.
| Attribute | Acceptance Criteria (Predicate) | FotoDent® denture Performance (Reported) |
|---|---|---|
| Indications | ||
| Manufacturing of full dentures | Yes | Yes |
| Manufacturing of partial dentures | Yes | Yes |
| Physical Property | ||
| Type 4 (light-activated) acrylic resin | Yes (per ISO 20795-1) | Yes (per ISO 20795-1) |
| Before Curing (liquid state) | ||
| Viscosity | 1000 65 MPa | > 80 MPa |
| Flexural Modulus | > 2000 MPa | > 2000 MPa |
| Material Type | Resin based | Resin based |
| Chemical Characterization | Methacrylate/acrylate resins with photo-initiators, pigments and additives | Methacrylate/acrylate resins with photo-initiators, pigments and additives |
| Shelf Life | 2 years | 2 years |
| Storage | 15-25°C, Do not expose to direct sunlight | 18-28°C, Do not expose to direct sunlight |
| Physical Configuration | Supplied in liquid form | Supplied in liquid form |
| Shades | 4 shades of pink | 2 shades of pink |
| Application | 3D Printing | 3D Printing |
| Fabrication Type | Automated 3D printing of resin in multiple layers, each layer light-cured before adding next layer | Automated 3D printing of resin in multiple layers, each layer light-cured before adding next layer |
| Polymerization (Curing Method) | Light-curing resin | Light-curing resin |
| Post Curing | light-curing unit | light-curing unit |
| Teeth Assembly | Bonding | Bonding |
| Sterile | No | No |
| Single Use | No | No |
| Environment of Use | Dental Laboratory | Dental Laboratory |
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.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.