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510(k) Data Aggregation
(294 days)
rainbow™ Paste Stain is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
rainbow™ Paste Stain is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid. The subject device is composed of 16 shade paste and thinner (Paste Stain Liquid), does not include powder only. The thinner is used to control viscosity of paste. Each paste has 3 volumes of 3g, 5g and 7g. The kit package is composed of various pastes and a liquid. The subject device is not intended to be marketed with multiple components or accessories. It is only composed with the products in this submission which are powder and liquid.
Here's a breakdown of the acceptance criteria and study information for the rainbow™ Paste Stain, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the requirements for Type I - Class I dental ceramics as outlined in ISO 6872:2008.
| Performance Metric | Acceptance Criteria (ISO 6872:2008 for Class I) | Reported Device Performance (rainbow™ Paste Stain) | Predicate Device Performance (Vita VM®) | Comparison and Compliance |
|---|---|---|---|---|
| Bending Strength (Flexural Strength) | > 50 MPa | 79 MPa | approx. 100 MPa | Satisfied: Although lower than the predicate, it is significantly higher than the minimum requirement. |
| Chemical Solubility (µg/cm²) | < 100 µg/cm² | 24 µg/cm² | approx. 10 µg/cm² | Satisfied: Meets the requirement, though higher than the predicate. |
| Linear Thermal Expansion Coefficient | Not explicitly stated as a hard limit in the document, but assessed for similarity/compatibility with firing schedules. | (9.5 ± 0.5) x 10⁻⁶ K⁻¹ | (9.0 ~ 9.2) x 10⁻⁶ K⁻¹ | Similar: Within a comparable range, and considered in conjunction with the firing schedule. |
| Glass Transition Temperature | Not explicitly stated as a hard limit in the document, but assessed for similarity/compatibility with firing schedules. | 476 °C | approx. 600 °C | Differences noted: However, "the subject and predicate device have each firing schedule reflecting these two technological characteristics." This implies the device is used with appropriate firing parameters. |
| Biocompatibility | Biocompatible (based on ISO 10993 series) | Biocompatible | Biocompatible | Satisfied: Tested and deemed biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific bench test (bending strength, chemical solubility, etc.) for the subject device or the predicate device. It also does not provide details on the data provenance in terms of country of origin or whether the data was retrospective or prospective. The testing was described as "non-clinical device testing" for performance comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a dental material, and its performance is evaluated through bench testing against established international standards (ISO 6872:2008), not through human expert assessment of a test set where a "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective measurements from bench tests against a standard, not on expert opinion requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret results, and the document describes a dental material evaluated through bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI is not applicable. This device is a physical dental material, not a software algorithm. The "standalone" performance here refers to the device's intrinsic material properties as measured by bench tests.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of rainbow™ Paste Stain is the ISO 6872:2008 international standard for dentistry - ceramic materials. The device's performance metrics were measured and compared directly against the specified requirements of this standard for Type I - Class I dental ceramics.
8. The Sample Size for the Training Set
This information is not applicable. There is no concept of a "training set" for this type of device (dental material). The device's formulation and manufacturing processes are likely developed based on scientific principles and internal R&D, not through machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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