(29 days)
Used to veneer metal substructures for fixed prosthodontics
The PTM™ SYSTEM is a press to metal system that consists of dental ceramic veneering materials designed for use in fixed prosthodontics devices that include both anterior and posterior crowns/bridges.
The PTM™ SYSTEM consists of an Opaque porcelain, Dentin/Enamel translucent ingots, Enamel Effect Porcelains, and a Glaze/Stain porcelain.
The provided 510(k) summary for the DENTSPLY PTM™ SYSTEM does not contain information on acceptance criteria or a study proving that the device meets such criteria. This document is a premarket notification for a dental ceramic veneering material, focusing on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against predefined acceptance criteria.
The information typically found in a 510(k) summary relates to the device's description, intended use, technological characteristics, and comparison to a predicate device. It usually does not include detailed clinical or performance study data with acceptance criteria, sample sizes, ground truth establishment, or expert adjudication methods as would be present for a novel or higher-risk device requiring such evidence.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.
The document states:
- "We believe that the prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the PTM™ SYSTEM for the intended use."
This statement indicates that the submission relies on the established safety and effectiveness of a predicate device and the minor nature of the changes, rather than a new performance study with explicit acceptance criteria.
§ 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.