(60 days)
Additively Manufactured Denture Resin is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
Additively Manufactured Denture Resin is intended for continuous use in the oral environment, exclusively for professional dental work.
Additively Manufactured Denture Resin can be used in combination with a DLP 3D printers utilizing wavelengths at 385nm or 405nm. A 3D-printer is not part of the device.
Additively Manufactured Denture Resin is a light-cured one-component materials for dental professional use only and intended for the fabrication of full and partial removable dentures. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. For use in Digital Light Processing (DLP)-3D printers utilizing wavelengths at 385nm or 405nm. The specifications of this product are divided into 500g, 1000g, 5kg and 10kg according to the weight of the resin liquid.
The provided document is a 510(k) summary for a medical device called "Additively Manufactured Denture Resin." It presents information about the device's intended use, technological characteristics, and a comparison to a predicate device to establish substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and study details:
Device: Additively Manufactured Denture Resin
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to adherence to the international standard ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers for physical and mechanical properties. The specific acceptance criteria within this standard are not explicitly listed in a table, but the document states:
| Acceptance Criteria Category (referencing ISO 20795-1) | Reported Device Performance |
|---|---|
| Homogeneity | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Surface Characteristics | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Shape Capability | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Color | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Color Stability | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Translucency | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Freedom From Porosity | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Ultimate Flexural Strength | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Flexural Modulus | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Total Fracture Work | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Maximum Stress Intensity Factor | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. Also explicitly states "Meet the requirements of ISO 20795-1:2013" in Table 1. |
| Surface Hardness | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Bonding To Synthetic Polymer Teeth | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Water Sorption | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Solubility | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Impact Resistance | Demonstrated performance to the acceptance criteria referred to ISO 20795-1 for Type 4 light-activated materials. |
| Biocompatibility | Complies with ISO 10993-1:2018, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-11 (for Acute Systemic Toxicity), ISO 10993-11 (for Subacute/subchronic systemic toxicity), ISO 10993-3, and ISO 7405:2018. |
| Shelf-Life | 2 years |
2. Sample size used for the test set and the data provenance:
The document states "Bench Testing: Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers." It also mentions "Biocompatibility Testing was performed according to FDA currently-recognized versions of biocompatibility consensus standards..."
However, the specific sample sizes for these tests are not provided in the document. The data provenance is related to laboratory bench testing and biocompatibility testing, indicating a controlled laboratory environment rather than direct patient data. The origin of the testing (e.g., country) is not specified beyond the manufacturer being from China.
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 in this context. The document describes the testing of a material's physical, mechanical, and biological properties against established international standards (ISO 20795-1, ISO 10993 series). Ground truth in this case is defined by these standards and the protocols for carrying out the tests, rather than by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. The testing involves objective measurements against predefined criteria in laboratory settings, not clinical interpretation requiring adjudication.
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:
This is not applicable. The device is a "Denture Resin," a material used for fabricating dental prostheses, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a material, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance claims for the denture resin is based on established material science standards and biocompatibility guidelines (ISO 20795-1, ISO 10993, ISO 7405). These standards define the test methods and acceptance limits for various physical, mechanical, and biological properties.
8. The sample size for the training set:
This is not applicable. The device is a material product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of 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.