(60 days)
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Not Found
No
The description focuses on the material properties and chemical composition of a temporary dental restorative material. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a temporary restorative material used in dentistry to protect a prepared tooth surface during the interim period until a permanent restoration is available, and to provide an esthetically pleasing appearance. It is not described as treating or preventing any disease or condition.
No
The device description indicates that TempFil F is a temporary restorative material used in dentistry to protect prepared tooth surfaces and provide esthetic appearance until a permanent restoration is available. It is a treatment material, not a device used for diagnosis.
No
The device description clearly describes a physical material (paste) used for dental restorations, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary dental restorations to protect prepared tooth surfaces and provide esthetics during the fabrication of permanent restorations. This is a direct treatment/restorative application within the oral cavity.
- Device Description: The description details the material composition and physical properties designed for dental restoration, not for analyzing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a material used directly in the mouth for a restorative purpose.
N/A
Intended Use / Indications for Use
Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim period is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.
Product codes
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Device Description
Kerr's TempFil F is designed to fulfill all of the requirements of a successful temporary restorative material. These requirements are itemized below:
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Ease of placement. TempFil F is supplied in two formulations identified as Inlay and Onlay. The Inlay formula is slightly less filled and this lower viscosity paste will flow easily into the complex preparation configurations of the typical inlay type restoration. Conversely, the onlay formula, with its' higher filler loading, results in a stiffer paste more suited to the sculpting and packing associated with a typical onlay type restoration.
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These two formulations have also been adjusted to accomodate the different service conditions experienced by the two distinct types of restoration in the oral environment. The onlay paste contains an additional crosslinking monomer not found in the inlay material. This additional crosslinking results in a harder surfaced restoration which is better able to withstand forces exerted by opposing dentition. These forces are more prevalent in an onlay type restoration.
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Convenience. The visible light activated curing characteristic of this no mix system is quicker and easier for the dentist to accomplish than the traditional chemically cured mixed catalyst and base systems.
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Ease of removal. Both formulations contain a monomeric component that allows the cured material to maintain the degree of elasticity required for easy removal when the final restoration is available. This elasticity helps to prevent damage to prepared margins during removal.
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Both formulations contain a fluoride release agent to impart the benefits of fluoride even during temporary use.
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The kit contains a syringe of Relief, a water soluble gel that is designed to prevent adhesion to glass ionomer and composite resin based liners placed under the TempFil F restorative.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Effectiveness or suitability to the intended purpose of Kerr TempFil F has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market. Results of this bench testing indicates that Kerr TempFil F Temporary Restorative Material performs as well or better than Fermit (Mfg. by Vivadent), E-Z Temp (Mfg. by Cosmedent), Clip ( Mfg. by Voco), three predicate devices currently on the market
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fermit (Mfg. by Vivadent), E-Z Temp (Mfg. by Cosmedent), Clip ( Mfg. by Voco)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
KA63786
NOV 1 9 1996
Page 1 of 2
510 ( k ) Summary
Statement of Safety an Effectiveness
Kerr TempFil F Temporary Restorative Material
BACKGROUND
Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim period is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.
TEMPFIL F
Kerr's TempFil F is designed to fulfill all of the requirements of a successful temporary restorative material. These requirements are itemized below:
-
Ease of placement. TempFil F is supplied in two formulations identified as Inlay and Onlay. The Inlay formula is slightly less filled and this lower viscosity paste will flow easily into the complex preparation configurations of the typical inlay type restoration. Conversely, the onlay formula, with its' higher filler loading, results in a stiffer paste more suited to the sculpting and packing associated with a typical onlay type restoration.
-
These two formulations have also been adjusted to accomodate the different service conditions experienced by the two distinct types of restoration in the oral environment. The onlay paste contains an additional crosslinking monomer not found in the inlay material. This additional crosslinking results in a harder surfaced restoration which is better able to withstand forces exerted by opposing dentition. These forces are more prevalent in an onlay type restoration.
-
Convenience. The visible light activated curing characteristic of this no mix system is quicker and easier for the dentist to accomplish than the traditional chemically cured mixed catalyst and base systems.
-
Ease of removal. Both formulations contain a monomeric component that allows the cured material to maintain the degree of elasticity required for easy removal when the final restoration is available. This elasticity helps to prevent damage to prepared margins during removal.
-
Both formulations contain a fluoride release agent to impart the benefits of fluoride even during temporary use.
-
The kit contains a syringe of Relief, a water soluble gel that is designed to prevent adhesion to glass ionomer and composite resin based liners placed under the TempFil F restorative.
1
SAFETY
The safety of Kerr TempFil F has been demonstrated by subjecting cured samples of the material to various types of biocompatibility tests as recommended in the ISO 10993 biocompatibility guidance standard. These tests were conducted by an independent laboratory which specializes in safety and toxicity evaluation. The tests include:
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- Ames Mutagenicity Assay
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- Cytotoxicity Study ( Agarose Overlay )
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- Kligman Maximization Study ( Tissue Sensitization )
EFFICACY
Effectiveness or suitability to the intended purpose of Kerr TempFil F has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate devices currently on the market. Results of this bench testing indicates that Kerr TempFil F Temporary Restorative Material performs as well or better than Fermit (Mfg. by Vivadent), E-Z Temp (Mfg. by Cosmedent), Clip ( Mfg. by Voco), three predicate devices currently on the market