(32 days)
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No
The device description and performance studies focus on the chemical properties and physical effects of an aqueous solution, with no mention of computational analysis, algorithms, or learning processes.
No.
The device, WET-PREP, is described as an aqueous re-wetting agent (dentin conditioner) used to prepare tooth structure for dental adhesives. It is not used for treating, preventing, or mitigating disease.
No
Explanation: The device description states that WET-PREP is an aqueous re-wetting agent used to prepare the dental cavity for restoration after acid etching. Its purpose is to keep the prepared tooth adequately moist for subsequent application of a hydrophilic dentin adhesive. There is no indication that this device is used to diagnose or detect any condition; instead, it is a treatment adjunct.
No
The device description clearly states it is an "aqueous solution" and a "re-wetting agent," indicating it is a chemical substance, 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 re-wet dried dentin following acid etching and drying of a prepared cavity. This is a procedure performed directly on the patient's tooth structure during a dental restoration process.
- Device Description: The device is an aqueous solution applied to the tooth structure. It's a re-wetting agent used in a clinical setting.
- Anatomical Site: The device is applied to the tooth structure, specifically dentin and enamel.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
The device is a dental material used in a clinical procedure, not a diagnostic test performed on a biological sample.
N/A
# Intended Use / Indications for Use
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity.
# Product codes (comma separated list FDA assigned to the subject device)
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# Device Description
WET-PREP is an aqueous solution of hydroxyethyl methacrylate. Hence, it is an aqueous re-wetting agent (dentin conditioner) that is applied to acid etching tooth structure, by the dentist following prior to application of a hydrophilic dentin adhesive such as ALL-BOND 2. The purpose of WET-PREP is to keep the dental cavity preparation adequately moist before the dentist restores the lost tooth structure.
# 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
Dentin, Enamel, Tooth structure
# Indicated Patient Age Range
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# 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)
It was found that WET-PREP significantly improved (greater than four fold increase) the shear bond strength of air dried dentin. This is a good indication of the product's efficacy. Desiccated dentin could be reconstitued so no significant difference could be found between treated teeth and those that were handled in a clinically acceptable fashion.
It was found that there was no statistically significant difference (p=0.05, t=1.29) between the shear bond strength of WET-PREP treated teeth and those left untreated. This was taken as an indication that WET-PREP did not significantly interfere with the bonding mechanism of the primer resins and the prepared tooth. However, WET-PREP treated teeth were found to have significantly greater shear bond strength when compared to HEMA-BENZ treated teeth (p=0.5, f=3.39).
# 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.
Bisco DENTIN CONDITIONER™, HEMA-BENZ™
# 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
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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.
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BISCO, INC., 1500 W. Thorndale Ave., Itasca, IL 60143 510(k) submission for WET-PREP™
Image /page/0/Picture/1 description: The image shows a series of numbers and a letter. The numbers are 961822. The letter is K. The numbers and letter are written in a bold, black font.
510(k) SUMMARY As Required By the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE
PREDICATE DEVICE Bisco DENTIN CONDITIONER™
DENTIN CONDITIONER is an aqueous solution of hydroxyethyl methacrylate (HEMA), and succinic acidhydroxyethyl methacrylate (SA-HEMA). The product was used at a time when acid etching dentin was unheard of. The product was intended to diffuse into the dentin smear layer and enhance the mechanical bond of subsequently applied bonding resins. The supporting hypothesis was sound in that aqueous solutions ought to easily penetrate the hydrophilic smear layer. After evaporation of the water solvent the acrylic monomers could then wet and bond to the relatively hydrophobic bonding resins (bis-GMA). Both the conditioners and bonding resins could polymerize together effecting a seal of the cut dentin.
PREDICATE DEVICE (cont). HEMA-BENZ™
HEMA-BENZ is functionally and chemically similar to DENTIONER noted above. The product is intended to perform identical service but HEMA-BENZ is also referred to as a desensitization. " it occurs at all, is due to the indirect effect of enhanced wetting of subsequent applications of primer resins. I hat is, reduction of sensitivity is due to the enhanced seal provided by the primers, the enhancement of the seal occurs through improved wetting provided by the products in question.
DESCRIPTION OF APPLICANT DEVICE WET-PREP™
WET-PREP is an aqueous solution of hydroxyethyl methacrylate. Hence, it is an aqueous re-wetting agent (dentin conditioner) that is applied to acid etching tooth structure, by the dentist following prior to application of a hydrophilic dentin adhesive such as ALL-BOND 2. The purpose of WET-PREP is to keep the dental cavity preparation adequately moist before the dentist restores the lost tooth structure.
It is well known that ALL-BOND 2 and similar hydrophilic primer resin systems are most effective when applied to moist dentin as in the so-called wet technique'. Some dentists have had difficulty determining exactly how wet to leave the dentin prior to application of hydrophilic primers. Brief drying with an air syringe prior to primer application often leads to desiccation of dentin with resultant collapse of collagen fibers. Collapsed collagen presents an effective barrier to penetration of primers.
Using the WET-PREP technique, the dentist can dry the cavity preparation following acid etching to assess the degree of enamel etching without fear of affecting the primer bond. The dentist simply re-wets with WET-PREP prior to application of the hydrophilic primer. WET-PREP precludes asking the familiar question, .10w wet is wet?"
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INTENDED USES OF APPLICANT DEVICE
VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity. Following etching the dentist typically air dries the etched enamel to check that a chalky-white appearance is present indicating that etching has occurred. At this point the dentin and enamel are too dry for effective penetration of subsequently applied primers. Hydrophilic primers will not effectively penetrate the dried collagen layer. If the primer is unable to penetrate through collagen an effective seal will not occur and postoperative sensitivity is likely to result.
If WET-PREP is applied prior to application of the primers, it will effectively re-wet the collapsed collagen and allow for penetration of the hydrophilic primers through the moist collagen network. Enhancement of penetration of primers will improve the seal the restorative material makes with the prepared tooth. Since it is well known that microleakage is the predominant reason for post-operative sensitivity it is reasonable to assume an increase in sensitivity ought to result from the use of these products.
SCIENTIFIC CONCEPTS and SIGNIFICANT PERFORMANCE CHARACTERISTICS
WET-PREP ia an aqueous solution of hydroxyethyl methacrylate (approx. 35%) with a small amount (