(60 days)
Luxatemp ( DMG ), Protemp Garant ( ESPE ), Integrity ( L. D. Caulk )
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No
The document describes a temporary dental restorative material and its dispensing mechanism. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are bench testing comparing the material to predicate devices.
No
The device is a temporary restorative material used in dentistry to protect prepared teeth and provide aesthetics during the fabrication of permanent restorations, not to treat a disease or condition.
No
The device is a temporary restorative material used in dentistry to protect prepared teeth and provide an esthetically pleasing appearance during an interim period, not for diagnosing conditions.
No
The device description clearly states it is a material supplied in a cartridge container, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the material is used for temporary restorative procedures in dentistry to protect prepared tooth surfaces and provide esthetics. This is a direct application within the patient's mouth, not a test performed on a sample taken from the body.
- Device Description: The description details a material dispensed from a cartridge for direct application. This aligns with a dental restorative material, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 beriod 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
TempFil C&B is supplied in a double barreled cartridge container which can be used with any of the currently available cartridge dispensers ( i.e. Kerr's Extrude mixer/extruder dispenser ) that will accept 1:1 mix ratio plungers. This allows the dentist to simultaneously mix and dispense the material directly into the impression or crown form.
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
Dentist
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)
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 )
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 C&B Temporary Restorative Material performs as well or better than three predicate devices currently on the market
- Kligman Maximization Study ( Tissue Sensitization )
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Luxatemp ( DMG ), Protemp Garant ( ESPE ), and Integrity ( L. D. Caulk )
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
FEB 1 0 1997
Page 1 of 2
510 ( k ) Summary
Statement of Safety an Effectiveness
Kerr TempFil C&B Temporary Restorative Material
Submitter
Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 (714) 516-7486 - Phone (714) 516-7488 - FAX William R. Pike - Contact Person
Device Name
Trade Name: TempFil C&B Common Name: Temporary Crown and Bridge Material Classification Name: Crown and Bridge Temporary, resin, per 21 CFR 872.3770
Devices for which Substantial Equivalence is Claimed
Luxatemp ( DMG ), Protemp Garant ( ESPE ), and Integrity ( L. D. Caulk )
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 beriod 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 C&B
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 C&B is supplied in a double barreled cartridge container which can be used with any of the currently available cartridge dispensers ( i.e. Kerr's Extrude mixer/extruder dispenser ) that will accept 1:1 mix ratio plungers. This allows the dentist to simultaneously mix and dispense the material directly into the impression or crown form.
-
Convenience. The automatic mixing tips eliminate the need for spatulae, mixing pads and placement instruments.
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:
-
- Ames Mutagenicity Assay
-
- Cytotoxicity Study ( Agarose Overlay )
-
- 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 C&B Temporary Restorative Material performs as well or better than three predicate devices currently on the market