(137 days)
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No
The description focuses on the material composition and mechanical properties of the dental restorative material, with no mention of AI or ML for design, manufacturing, or analysis.
No
The device is described as a material for constructing cosmetic prosthetic dental restoratives, which falls under restoration rather than therapeutic treatment.
No
The device is a restorative material used to construct cosmetic prosthetic dental restoratives, not to diagnose a condition.
No
The device description clearly describes a physical material (layered composite restorative glass strength materials) used to construct dental prosthetics. There is no mention of software as the primary component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to construct cosmetic prosthetic dental restoratives for fixed restorations. This is a direct treatment/restoration of a physical structure (teeth), not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the material composition and properties of a dental restorative material. It doesn't describe a test or assay used to analyze a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
This device falls under the category of a dental restorative material, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Newave Medical CRISTOBAL, the Heraeus Kulzer ArtGlass, and the Kulzer Dentacolor are intended to be used for construction of cosmetic prosthetic restoratives for use in fixed restorations, with or without metal frameworks for:
- single crowns, .
- telescope crowns, .
- conus crowns, .
- bridges, (with metal-frame) ●
- Maryland bridges, .
- bridges on implants, .
- inlays, .
- onlays .
- facettes (laminate veneers), and ●
- restorations. .
Product codes
EBF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY | 9 1998
SMDA Summary of Safety and Effectiveness - "510(k) Summary" 8.
- A. Submittor Information
Newave Medical Inc. c/o Interactive Consulting Ins. 70 Walnut Street Wellesley, MA 02181
Telephone: 617 239-8108
Jean-Luc Boulnois Contact Person: Secretary
December 26, 1997 Date Prepared:
B. Device Identification
Common/Usual Name Proprietary Name:
Glass Strength Restorative Dental Materials CRISTOBAL
C. Identification of Predicate Device(s)
CRISTOBAL is substantially equivalent to the following previously cleared and currently marketing devices:
Kulzer Dentacolor (K831215) Heraeus Kulzer ArtGlass (K954115)
D. Device Description
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.
1
E. Substantial Equivalence
The technical characteristics of CRISTOBAL are almost identical to those of the Heraeus Kulzer ArtGlass and the Kulzer Dentacolor. Refer to Table A for a comparison of these predicate devices. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems, do not affect the relative safety or effectiveness of the CRISTOBAL materials.
The Newave Medical CRISTOBAL, the Heraeus Kulzer ArtGlass, and the Kulzer Dentacolor are intended to be used for construction of cosmetic prosthetic restoratives for use in fixed restorations, with or without metal frameworks for:
- single crowns, .
- telescope crowns, .
- conus crowns, .
- bridges, (with metal-frame) ●
- Maryland bridges, .
- bridges on implants, .
- inlays, .
- onlays .
- facettes (laminate veneers), and ●
- restorations. .
2
TABLE A Comparison Table: Restorative Dental Materials
ﺃﺳﺴﻪ ﺍﻟ
| Manufacturer: | Kulzer | Heraeus Kulzer | Newave Medical Inc |
|---|---|---|---|
| Model | |||
| K-Number | DENTACOLOR | ||
| K831215 | ARTGLASS | ||
| K954115 | CRISTOBAL | ||
| Class | II | II | Request II |
| Properties of Strength: | |||
| Bending/Flexural (MPa) | |||
| Modulus Flexibility (MPa) | |||
| Comprehensive (MPa) | |||
| Vickers-Hardness (N/mm²) | |||
| Fracture Damage during Vickers Hardness | |||
| Tests (mm²) | |||
| Abrasion (µm/year) | |||
| Bulk Modulus NFT 51101 (MPa) | |||
| Water Solubility (ug/mm²) | 70-75 | ||
| 3300 - 3500 | |||
| 350 | |||
| 400 | |||
| Not Available | |||
| Not Available | |||
| Not Available | |||
| 1 | 120 | ||
| 9 000 | |||
| Not Available | |||
| 590 | |||
| Not Available | |||
| Good | |||
| Not Available | |||
| 0.5 | 155 | ||
| 8 500 | |||
| 350 | |||
| 670 | |||
| 0,245 |