(169 days)
Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.
Kingscross, which was developed by Kettenbach, is a highly esthetic composite of fabricating temporary restorations. The two-component system based on a multifunctional acryl composite is produced using no Bisphenol-A or Bisphenol-A precursors in the manufacturing process It has similar properties to a filling material and is available in the following shades: A1. A2, A3, A3.5, B1, B3, Bleach white. Kingscross temporary restorations can also be adjusted and customized using lightcuring composites. The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun. By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.
The provided 510(k) summary for K122039, Kingscross Temporary Crown and Bridge Material, does not contain a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML or diagnostic device.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of material properties and intended use. The "acceptance criteria" here are implied by the performance of the predicate devices and the relevant industry standards for dental materials.
Here's an analysis based on the provided text, addressing the requested information to the best of its ability given the type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a dental material, the "acceptance criteria" are not quantitative thresholds set for a specific study, but rather that the material's properties are comparable to established predicate devices and meet relevant industry standards.
| Acceptance Criteria (Implied by Predicate Devices & Standards) | Reported Device Performance (Kingscross) |
|---|---|
| Biocompatibility: | "Kingscross materials' biocompatibility data is comparable to other materials on the market." (ISO 10993 family tests: cytotoxicity, mutagenicity, sensitization, mucosa irritation, chemical analysis) |
| Mechanical Properties (Comparable to Predicate Devices & Industry Standards): | "The results indicate adequate strength results compared to leading temporary crown and bridge materials." "A comparison of the mechanical properties has also been performed in respect to the parameters and standards referenced under 'Summary of Non-Clinical Performance Testing'. The results also demonstrate substantial equivalence to the predicate devices." (Specific tests include: E-Modulus, Flexible strength, Impact strength, Compressive strength, Diametral tensile strength, Volume shrinkage, Max. temperature on cure, Inhibition layer, Extrusion force, as measured by ADA/ANSI and ISO standards). |
| Intended Use: For fabrication of temporary prostheses (crowns, bridges, inlays, onlays, etc.). | "Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated." (This matches the intended use of predicate devices, with some slight expansion for "customization" and "long-term temporary restorations" but argued as "no significant difference in intended use or technology"). |
| Technology/Application: 2-paste system, dispensing gun, cartridge, mixing tip. | Matches predicate devices. |
Regarding the other requested information:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes bench testing of material properties (E-Modulus, flexible strength, etc.) and biocompatibility tests.
- Sample sizes for these material tests are not specified. For example, it doesn't state how many samples were tested for compressive strength or E-Modulus for Kingscross or the predicate devices.
- Data provenance is not explicitly stated, but given the manufacturer is Kettenbach GmbH & Co KG in Germany, it's highly likely these tests were performed in Germany or by contract labs following international standards. These would be prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the traditional sense for this device. This is a material claim, not a diagnostic or AI device that requires expert ground truth labeling of images or clinical cases. The "ground truth" here is adherence to established material testing standards (e.g., ADA/ANSI Specification No. 53, ISO 9917-1, OECD 487 for biocompatibility). The experts would be the chemists and material scientists performing and interpreting these standardized tests, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no expert adjudication process described for the quantitative material property tests. The results are objective measurements from standardized tests.
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
- No. This is not an AI/ML device or a diagnostic device involving human readers. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a dental material, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established industry standards and the measured physical and chemical properties of the material itself, as well as the performance characteristics of the legally marketed predicate devices. No pathology, outcomes data, or expert consensus (in the clinical diagnosis sense) was used to establish ground truth for this type of submission.
8. The sample size for the training set
- Not applicable. This device is a material, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
§ 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.