(163 days)
SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:
- Light Pink
- Original Pink
- Light Meharry
- Original Meharry
- Extra Light Pink
- Medium Pink
- Dark Pink
- Dark Meharry
- Deep Dark Meharry
SprintRay Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
The SprintRay Denture Base is a light-curable polymerizable resin used for the fabrication and repair of full and partial removable dentures and baseplates. The 510(k) summary provides details on the performance data, primarily bench testing, to demonstrate substantial equivalence to the predicate device, Dentca Denture Base (K143033).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SprintRay Denture Base are based on conformity with the industry consensus standard ISO 20795-1 for dental base polymers, as well as biocompatibility standards. The reported performance indicates that the device met these criteria.
| Acceptance Criteria Category | Specific Test Standard / Parameter | Acceptance Criteria (Implicit from ISO 20795-1 and ISO 10993-1) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Genotoxicity | Conforming to ISO 10993-1 and ISO 7405 requirements | SprintRay Denture Base considered tissue contacting for >30 days, passed all tests; functioned as intended, outcomes as expected. |
| Cytotoxicity | Conforming to ISO 10993-1 and ISO 7405 requirements | Functioned as intended, outcomes as expected. | |
| Acute Systematic Toxicity | Conforming to ISO 10993-1 and ISO 7405 requirements | Functioned as intended, outcomes as expected. | |
| Sensitization | Conforming to ISO 10993-1 and ISO 7405 requirements | Functioned as intended, outcomes as expected. | |
| Irritation | Conforming to ISO 10993-1 and ISO 7405 requirements | Functioned as intended, outcomes as expected. | |
| Bench Testing | Flexural Strength and Modulus | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. |
| Water Sorption and Solubility | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Stability | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Residual Methyl Methacrylate Monomers | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Homogeneity | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Surface Characteristics | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Shape Capability, Translucency, and Polishability | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Freedom from Porosity | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. | |
| Color Stability | Conforming to ISO 20795-1 | Functioned as intended, outcomes as expected. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the biocompatibility or bench testing. It refers to "battery of testing" for both categories. The provenance of the data is implicit as part of a regulatory submission to the FDA, suggesting the tests were conducted by or for SprintRay Inc. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but for bench and biocompatibility testing of a material, these distinctions are generally less relevant than for clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For bench chemistry and physical property testing, "ground truth" is typically established by certified laboratory equipment and validated test methods, not human expert consensus, so this question is not directly applicable in the usual sense for this type of device.
4. Adjudication method for the test set
Not applicable, as the performance testing described is primarily objective laboratory testing against established standards, not interpretation by human experts.
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. The SprintRay Denture Base is a dental material, not an AI-powered diagnostic or assistive device for human readers. No MRMC study or AI assistance is mentioned or relevant to this device's performance testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used
For biocompatibility testing, the ground truth is established by the accepted biological responses and safety profiles defined in international standards (ISO 10993-1 and ISO 7405) for medical devices.
For bench testing, the ground truth is established by the specified material properties and performance requirements outlined in the industry consensus standard ISO 20795-1 for dental base polymers. The results of physical and chemical tests are compared against the limits and ranges defined by this standard.
8. The sample size for the training set
Not applicable. This device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI or similar algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.