(65 days)
No
The device description focuses on the chemical composition and packaging of a dental restorative material, with no mention of AI or ML technologies.
No
The device description indicates it is a dental composite restorative material, not a therapeutic device.
No
The description explicitly states "Prodigy AC autocure composite restorative material" and "Prodigy AC Core Buildup Material," indicating it is a restorative material used for dental fillings or core buildups, not for diagnosis.
No
The device description clearly describes a composite restorative material, which is a physical substance used in dentistry, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the material composition and intended use as a restorative material and core buildup material. There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Intended Use is not found: While the "Intended Use / Indications for Use" section is missing, the "Device Description" clearly describes the material as a "composite restorative material" and "Core Buildup Material." These are applications within dentistry for restoring or building up tooth structure, not for in vitro diagnostic purposes.
- No mention of analyzing biological samples: The description details the chemical components and packaging configurations, but there is no mention of interacting with or analyzing biological samples like blood, urine, or tissue.
Therefore, based on the information provided, this device falls under the category of a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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Device Description
Kerr has developed Prodigy Autocure Restorative and Core Buildup Material. This material is light cure Prodigy except for minor modifications in the polymerization chemistry and the addition of a small amount of a Fluoride release agent. Specifically, the camphorquinone / amine visible light initiation components were replaced with the traditional chemical cure additives, Benzoyl Peroxide in the catalyst paste and DHEPT [ N, N-Di-(2hydroxvethyl)-4-toluidine 1 in the base paste. To provide the benefits associated with a Fluoride releasing material, 2 % by weight Sodium Hexafluorosilicate ( Na,SiF ) was added to all paste formulations. Kerr intends to market this device in two distinct package configurations. The first, the Prodigy AC autocure composite restorative material, will be offered in a kit containing one 5 gram jar of catalyst paste along with one 5 gram jar of each of three base paste shades ( Light, Universal, and Dark ). The second, Prodigy AC Core Buildup Material, tentatively being referred to as ProCore, will be supplied in a kit containing one 5 gram syringes each of the catalysts ( High and Low Viscosity ), and one 5 gram syringe of a dual cure White base paste ( This paste formula will be light and chemically activated. ).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
The efficacy of this product, with respect to it's suitability to it's intended purpose, is demonstrated by the fact that when tested in side by side comparison with several predicate devices currently on the market, it performed as well or better than the predicate devices.
Key Metrics
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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
510 ( k ) Notification for Prodigy Autocure Restorative and Core Buildup Material
NOV 2 7 1996
510 ( k ) Summary
Statement of Safety an Effectiveness
BACKGROUND
In the spring of 1995, Kerr began distribution of a new visible light cured composite restorative material under the tradename, Prodigy ( Reference: K944659 ). The product gained rapid acceptance and is now one of the market leaders among light cure composite restoratives. The reason for this success, is that Prodigy is the current embodiment of a fourth generation of continuously improving anterior/posterior restorative technology. The ancestors include Herculite Condensable Posterior Composite ( 1984 ), Herculite XR anterior/posterior composite ( 1986 ), Herculite XRV universal composite in vita shades ( 1992 ). Prodigy's unique resin chemistry results in an ideal working viscosity, while the small particle hybrid filler provides superior durability and polishability. All of this with the life-like aesthetics of Vita shading has made Prodigy the restorative material of choice of thousands of clinicians.
PRODIGY AC
In response to customer feedback and many requests from the field, Kerr has developed Prodigy Autocure Restorative and Core Buildup Material. This material is light cure Prodigy except for minor modifications in the polymerization chemistry and the addition of a small amount of a Fluoride release agent. Specifically, the camphorquinone / amine visible light initiation components were replaced with the traditional chemical cure additives, Benzoyl Peroxide in the catalyst paste and DHEPT [ N, N-Di-(2hydroxvethyl)-4-toluidine 1 in the base paste. To provide the benefits associated with a Fluoride releasing material, 2 % by weight Sodium Hexafluorosilicate ( Na,SiF ) was added to all paste formulations. Kerr intends to market this device in two distinct package configurations. The first, the Prodigy AC autocure composite restorative material, will be offered in a kit containing one 5 gram jar of catalyst paste along with one 5 gram jar of each of three base paste shades ( Light, Universal, and Dark ). The second, Prodigy AC Core Buildup Material, tentatively being referred to as ProCore, will be supplied in a kit containing one 5 gram syringes each of the catalysts ( High and Low Viscosity ), and one 5 gram syringe of a dual cure White base paste ( This paste formula will be light and chemically activated. ). A detailed description of both of these kit contents is provided later in this submission.
SAFETY
The safety and biocompatibility of the cured state methacrylate monomer based, glass filled composite restorative materials is well established in the dental community. Since the formulation of this product is so similar to the original Prodigy material ( Ref: K944659 ) there is no reason to suspect that the slight modifications made to additive components would adversely effect the safety and biocompatibility of this device. Copies of the original Prodigy test results are being included elsewhere in this submission for your review.
EFFECTIVENESS
The efficacy of this product, with respect to it's suitability to it's intended purpose, is demonstrated by the fact that when tested in side by side comparison with several predicate devices currently on the market, it performed as well or better than the predicate devices. Results of this comparison testing is provided elsewhere in this submission.