(115 days)
LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 100 shades are available in 10ml, 30ml, 50ml, 50ml and 100ml volumes. Luxen CL-Diluent and Luxen CL-Pontic Liquid are used to dilute the color of other products. Luxen CL-Pontic and Luxen-CL Diluent is used to dilute Base liquid and special color liquid.
This document describes the premarket notification (510(k)) for LUXEN CL Dental Liquid. The information provided heavily focuses on establishing substantial equivalence to a predicate device rather than detailing extensive performance studies with specific acceptance criteria and detailed quantitative results for the device itself.
Based on the provided text, here's an attempt to answer your questions, highlighting where information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific quantitative performance metrics for the LUXEN CL Dental Liquid for color outcomes. Instead, it relies on demonstrating substantial equivalence through biocompatibility testing and general performance observation.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993 standards for dental materials | "All the test results support substantial equivalence to the predicate devices." (Specific results not given) |
| - Cytotoxicity | Pass ISO 10993-5 | Tested (Pass implied) |
| - Sensitization & Irritation | Pass ISO 10993-10 | Tested (Pass implied) |
| - Oral mucosa irritation | Pass ISO 10993-11 | Tested (Pass implied) |
| Physical Properties | Maintain specified appearance, volume, packaging, color stability, extraction properties over time. | Tested (Pass implied by "All the test results support substantial equivalence...") |
| - Appearance | Consistent with specifications | Tested |
| - Volume | As specified | Tested |
| - Packaging | Intact, functional, and protective | Tested |
| - Color Stability | Maintain intended color over product shelf-life | Tested |
| - Extraction | No harmful or excessive leachate | Tested |
| Shelf Life | Maintain characteristics over stated shelf life | Tested |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the performance tests. The document only lists the types of tests performed.
- Data Provenance: Not specified. It's presumably from DENTALMAX Co., Ltd. (Republic of Korea, as per registrant address), but whether internal or external lab, retrospective or prospective generation, is not stated.
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. This device is a dental coloring liquid, not an AI or diagnostic medical device requiring expert interpretation for ground truth. The performance tests are focused on physical and biocompatibility properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication for subjective interpretations.
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 not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (biocompatibility, physical properties, shelf life), the "ground truth" would be established by the adherence to the referenced ISO standards (e.g., ISO 10993-5 for cytotoxicity) and internal quality control specifications for physical attributes. There is no mention of external "ground truth" of the type relevant to diagnostic performance (e.g., pathology reports for disease detection).
8. The sample size for the training set
Not applicable. This is not an AI/ML device where a training set is used.
9. How the ground truth for the training set was established
Not applicable.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.