(74 days)
ZENO®PMMA Discs are milling blanks consisting of polymethylmethacrylate. They are designed for making long-term temporary crown and bridge work and have to be machined with the CAD/CAM technique. ZENO PMMA Discs are recommended for manufacturing substructures of single tooth and bridgework with one or two pontics.
ZENO PMMA Discs (A3/B1) are milling blanks composed of hot cured polymethylmethacrylate (PMMA). They are intended to be used by professional dental technicians for making long-term temporary crowns and bridgeworks for the sole use of particular patients.
ZENO PMMA Discs can be machined in all machines of the ZENO Tec system. The manufacturing process of the long-term temporary crowns and bridges consists of different steps. At first the model has to be scanned. In the next step, the restoration has to be designed virtually with the help of the CAD technology. Thereafter, the realization of this design has to be carried out by the CAM technology. In a final step the restoration can be individually characterised with dental veneering composites for improving the aesthetics and it can be pre- and high shine polished.
The ZENO PMMA Discs are offered in two different shades (A3, B1) and thicknesses.
The provided document is a 510(k) summary for a dental device (ZENO PMMA Disc). It does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (VITA CAD-TEMP). This is a different regulatory pathway than providing detailed performance studies against defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document. However, I can provide what information is available based on the request:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable: The document does not provide specific acceptance criteria or performance data for the ZENO PMMA Disc. It asserts "comparable physical, biological, and chemical properties" to the predicate device but does not quantify these or establish specific criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable: No clinical or laboratory performance study against specific criteria is described, so no test set sample size or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable: No ground truth establishment activity for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No adjudication for a test set is described.
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 is a material science device, not an AI or imaging device, so an MRMC study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a material science device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: No ground truth used for performance evaluation is described. The "ground truth" for regulatory submission in this case is the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not Applicable: This is a material science device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable: As above, no training set or ground truth for it is relevant or mentioned.
Summary of available information related to equivalence, as described in the document:
The regulatory submission asserts substantial equivalence based on:
- Identical indication for use: ZENO PMMA Discs and the predicate (VITA CAD-TEMP) are both used for making long-term temporary crowns and bridgeworks.
- Comparable material properties: Both devices are acrylate polymers and "have comparable physical, biological, and chemical properties." (No specific data provided in this summary to quantify "comparable").
- Similar function: Both devices have the "same prophylactic, diagnostic and aesthetic function."
The document states: "Due to the high polymerization grade and excellent material properties of the ZENO PMMA Discs, the restorations possess a high-level safety and effectiveness. ZENO PMMA Discs therefore are as safe, as effective, and performs as well as or better than the predicate device." This is the core argument for substantial equivalence rather than a detailed performance study against acceptance criteria.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.