(269 days)
Resin for Temporary Crown & Bridge is indication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.
The Resin for Temporary Crown & Bridge is made by Methacrylate Oligomer based on the Urethane Acrylate Oligomer with 0.01~0.1wt% inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It contains materials with colors of A2 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 405nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to 0.03 mm on the x, y axis. This device should use ZENITH 3D Printer equipment using UV light source of Dentis Co., Ltd., and it is possible to produce three dimensional printed matter by curing lamination step by step a thicknesses of 100, 50 and 16um.
The provided text is a 510(k) Summary for a medical device called "Resin for Temporary Crown & Bridge." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the device itself.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance data. Instead, it mentions that "Performance testing confirmed the Resin for Temporary Crown & Bridge demonstrated equivalent or better performance to the predicate device or acceptance criteria referred to ISO 10477." This implies that ISO 10477 serves as the acceptance criteria for certain performance aspects, and the device met or exceeded them without providing specific values.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but the testing was "non-clinical testing" conducted to validate the product against the company's specified design requirement.
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 and not provided. The study conducted was non-clinical testing focused on material properties and biocompatibility, not human interpretation or diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable. There was no human interpretation involved in establishing ground truth for this type of non-clinical testing.
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 material for dental restorations, not an AI-assisted diagnostic tool.
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 the non-clinical testing, the "ground truth" was established by standards and internal company specifications. Specifically:
- Biocompatibility was evaluated based on ISO 10993-3, EN ISO 10993-5, EN ISO 10993-10 and EN ISO 10993-11.
- Performance specifications (e.g., compressive & tensile loads, hardness, water sorption, solubility) were compared to the predicate device or acceptance criteria referred to ISO 10477.
8. The sample size for the training set:
Not applicable. This device is a material, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.