(56 days)
IPS InLine PoM is a leucite ceramic system for pressing fully anatomical restorations on metal crown and bridge frameworks after the application of opaquer; mainly in the posterior region. Alloy CTE range: 13.8 - 14.5 10°K-25-500 °C
The material is contraindicated for:
- Pressing over metal frameworks beyond the CTE range
- Very deep sub-gingival preparations
- Patients with substantially reduced residual dentition
- Patients with bruxism and
- Use with alloys with a silver content of more than 10%
Other limitations of use: - Combination with any other ceramic materials
- Pressing IPS InLine PoM ingots thinner than 0.8mm
- Pressing of IPS InLine PoM ingots without a metal framework
- Layering of IPS InLine Dentin, Incisal, Deep Dentin, Margin, Impulse and Gingiva materials
- Pressing over metal frameworks that do not exhibit the required minimum thickness for copings or connectors.
IPS InLine PoM is a dental porcelain system composed of a leucite-ceramic which utilizes a press-on technique for dental restoration fabrication. The restoration is processed according to the lost wax technique. The opaqued metal framework is first waxed up in the desired shape and function and invested. After investment and burning out of the wax, the ductile ceramic - IPS InLine PoM ingot, is pressed into the previously created hollow space by means of a press furnace. After divesting the pressed objects, they are individually characterized using the new Shade/Stain and Glaze materials intended to be marketed with this System.
The InLine PoM System consists of a porcelain Opaquer, Porcelain Ingots, Touch up and Add-On Porcelain powders, and Shade, Stain and Glaze porcelain pastes with accompanying liquids.
The provided text describes a dental ceramic system, the IPS InLine PoM System, and mentions its development and testing according to specific ISO standards for dental ceramics and metal-ceramic dental restorative systems (ISO 6872 and ISO 9693). However, the document does not contain an acceptance criteria table, reported device performance data, or details about a study that would typically be described with the requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The document is a 510(k) summary for a premarket notification for a Class II medical device, indicating that the manufacturer believes the device is substantially equivalent to legally marketed predicate devices. The safety and effectiveness are supported by the prior use of components, similarity in formulations, and data provided regarding modifications.
Therefore, I cannot provide the requested information from the given text as it does not contain details of a clinical or performance study with the level of detail asked in your prompt.
Summary of missing information based on your request:
- Table of acceptance criteria and reported device performance: Not present. The document only states that the device was designed and tested in accordance with ISO 6872 and ISO 9693.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
- Adjudication method for the test set: Not present.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a physical dental material, not an AI algorithm.
- Type of ground truth used: Not present.
- Sample size for the training set: Not applicable/not present.
- How the ground truth for the training set was established: Not applicable/not present.
§ 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.