(35 days)
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No
The device description and summary of performance studies focus on the chemical composition and adhesive properties of a dental adhesive, with no mention of AI or ML technology.
No
The device is a dental adhesive used for bonding restorative materials to teeth, not for treating a disease or condition.
No
The device is described as a dental adhesive, used for forming bonds between tooth structures and restorative materials, not for diagnosing conditions.
No
The device description clearly indicates it is a chemical substance (methacrylate resin based mixture) supplied in a bottle, 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 is to bond dental restorative materials to natural tooth structures. This is a direct application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description reinforces the intended use of bonding materials to teeth.
- Lack of IVD Characteristics: There is no mention of analyzing samples, diagnosing conditions, or providing information about a patient's health status based on testing biological specimens.
Therefore, this device is a dental adhesive used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacy late resin based mixture of monomers capable of forming both chemical addesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative inaterials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative material.
Mentions image processing
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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)
Safety of Kerr Advanced Adhesive has been demonstrated by subjecting cured samples of the adhesive 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
- Kligman Maximization Study ( Allergenic Potential Evaluation )
- Cytotoxicity Study ( MEM Elution Method USP 23 )
- Implantation Test ( Tissue Sensitization )
Effectiveness or suitability to the intended purpose of Kerr Advanced Adhesive has been demonstrated by a combination of in-house testing and side by side test comparisons to a predicate device currently on the market. Results of this bench testing indicates that Kerr Advanced Adhesive performs as well or better than PRIME & BOND, One-Step, and Tenure QUIK, three predicate devices currently on the market and being represented as one step all-purpose dental adhesives
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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
AUG - 1 1996
Page 1 of 1
510 ( k ) Summary
Statement of Safety an Effectiveness
Kerr Advanced Adhesive
Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacy late resin based mixture of monomers capable of forming both chemical addesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative inaterials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative material.
The safety of Kerr Advanced Adhesive has been demonstrated by subjecting cured samples of the adhesive 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
- 2.Kligman Maximization Study ( Allergenic Potential Evaluation )
-
- Cytotoxicity Study ( MEM Elution Method USP 23 )
-
- Implantation Test ( Tissue Sensitization )
Effectiveness or suitability to the intended purpose of Kerr Advanced Adhesive has been demonstrated by a combination of in-house testing and side by side test comparisons to a predicate device currently on the market. Results of this bench testing indicates that Kerr Advanced Adhesive performs as well or better than PRIME & BOND, One-Step, and Tenure QUIK, three predicate devices currently on the market and being represented as one step all-purpose dental adhesives