(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) |
§ 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.