(125 days)
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
The provided text describes a 510(k) premarket notification for "SYNTHETIC POLYMER TEETH". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, the document explicitly states:
- "Discussion of Clinical Tests Performed: None"
This means there was no clinical study conducted to establish performance and acceptance criteria for the device itself. Instead, the submission relies on the established safety and effectiveness of the predicate devices and the new device's material and manufacturing similarity to them.
As a result, I cannot provide the requested information in the format of acceptance criteria and reported device performance based on a study, as such a study was not performed as part of this 510(k) submission.
To answer your request based on the provided document, here's what can be extracted:
No Clinical Study Performed for this Device
The submission explicitly states that no clinical tests were performed to establish performance or meet specific acceptance criteria for the SYNTHETIC POLYMER TEETH.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. No acceptance criteria were defined or measured through a clinical study for this device as part of the 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices through non-clinical bench and biocompatibility testing.
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set and thus no ground truth established by experts for a test set.
4. Adjudication method for the test set
Not applicable. No clinical test set.
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 device is a preformed plastic denture tooth, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a preformed plastic denture tooth, not an algorithm.
7. The type of ground truth used
Not applicable. No clinical study was performed requiring ground truth.
8. The sample size for the training set
Not applicable. No machine learning model was developed for this device.
9. How the ground truth for the training set was established
Not applicable. No machine learning model was developed for this device.
§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.