(137 days)
To construct cosmetic prosthetic dental restoratives for use in fixed restorations with or without metal frameworks to include:
- single crowns,
- telescope crowns,
- conus crowns,
- bridges,
- Maryland bridges,
- bridges on implants,
- inlays,
- onlays
- facettes (laminate veneers), and
- restorations.
CRISTOBAL consists of a series of layered composite restorative glass strength materials, combining the benefit of porcelain, composite and dental alloys, whose combined properties of wear resistance, flexural strength, maximum compressive strength and bulk modulus, make it suitable for all types of fixed cosmetic prosthetic restorations. CRISTOBAL offers the patient a tooth colored occlusal surface with the feeling of natural teeth.
CRISTOBAL is subject to complete polymerization for optimal reactions of the various materials. Due to the fact that the light curing material of CRISTOBAL is radioand its matrix has a very high content in inorganic particles (barium opaque. borosilicate), it allows for the production of fixed prostheses with functional, mechanical, and cosmetic longevity.
CRISTOBAL is composed of silanized barium borosilicate particles, a non-fracturable filler material, which are closely packed (74.2 weight percent) providing optimal silanization and cohesion of glass thereby ensuring protection against fracture together, with strong resistance to damage. With the matrix of Bis-GMA, TEDMA and UDDMA, these elastic memory properties also ensure damage resistance.
Despite the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, the provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific performance thresholds.
Instead, the document is a 510(k) Pre-market Notification Summary for a dental restorative material called CRISTOBAL. The primary purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to present a standalone performance study against pre-defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an attempt to address the points based on the available information, highlighting where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, the document does not define specific "acceptance criteria" against which CRISTOBAL was tested in a dedicated study. Instead, it compares CRISTOBAL's properties to those of two predicate devices to demonstrate substantial equivalence.
| Property | Predicate Device 1 (Kulzer DENTACOLOR) | Predicate Device 2 (Heraeus Kulzer ARTGLASS) | CRISTOBAL (Reported Performance) |
|---|---|---|---|
| Bending/Flexural (MPa) | 70-75 | 120 | 155 |
| Modulus Flexibility (MPa) | 3300 - 3500 | 9 000 | 8 500 |
| Comprehensive (MPa) | 350 | Not Available | 350 |
| Vickers-Hardness (N/mm²) | 400 | 590 | 670 |
| Fracture Damage during Vickers Hardness Tests (mm²) | Not Available | Not Available | 0.245 |
| Abrasion (µm/year) | Not Available | Good |
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.