Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.

Device Description

Enamelite Acryseal Spray Sealant is a dental sealant or bonding agent which is packaged for aerosol dispensing. The product is formulated as either an acrylic spray sealer or composite spray sealer. The base product is identical to brush on sealants that have been used for over 40 years in the dental profession. The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method and was designed to replace the outdated brush application of sealing/bonding lacquer.

AI/ML Overview

The provided text is a 510(k) summary for the Enamelite Acryseal Spray Sealant and Enamelite Acryseal-CB Spray Sealant. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence and does not typically involve the detailed "acceptance criteria" and "study proving the device meets acceptance criteria" in the same way a novel device might go through a rigorous clinical trial with specific performance metrics.

Instead, the submission argues that the new device has "similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent" to predicate devices. This implies that the 'acceptance criteria' are met indirectly by demonstrating equivalence to devices already accepted by the FDA.

Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not directly available or applicable within this 510(k) summary.

Here's how to interpret the request in the context of the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by Substantial Equivalence): The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to one or more predicate devices. This means that the new device is as safe and effective as the predicate, either because it has the same technological characteristics, or if it has different characteristics, these do not raise new questions of safety and effectiveness, and the device is as safe and effective as the predicate.
Reported Device Performance: The document does not provide specific quantitative performance metrics like sensitivity, specificity, accuracy, or other statistical measures. Instead, it describes the physical and chemical properties and intended function of the device and states that these are equivalent to the predicate devices.
- Description: "The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method..."
- Technological Characteristics: Specifies compositions (Methyl Methacrylate Solids and Monomers for Acryseal, 2-Methyl-2-Propenoic Acid and Triethylene Glycol Dimethacrylate for Acryseal-CB, with potential fillers).
- Functionality: "Product is sprayed onto dental fixtures in very light or thin coats. The dental acrylic sealant begins its chemical bonding process as soon as the material hits the surface of the dental fixture. The acrylic sealant can be air cured in 5 minutes and the composite sealant can be light cured in 90 seconds. Spray sealant facilitates a smooth even layer of material when sprayed onto dental fixtures. Surface porosity and any scratches are sealed and smoothed over to a glossy smooth surface to make cleaning easier and help prevent the growth of harmful bacteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the 510(k) summary. For a 510(k) based on substantial equivalence to existing devices, extensive new clinical trial data or performance testing with specific "test sets" of data, as might be done for an AI/ML device, is often not required or detailed in the summary if the technological characteristics are sufficiently similar to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided as there is no mention of a "test set" and associated "ground truth" derived from expert review in the context of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/provided. This device is a dental sealant/bonding agent, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. This device is a physical product (a spray sealant), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided. The submission is not based on a ground truth derived from clinical data in the traditional sense for evaluating device performance against a gold standard. Instead, it relies on the known or established performance of predicate devices and the chemical/physical properties of the new device relative to those predicates.

8. The sample size for the training set:

This information is not applicable/provided. This is a physical product, not a software algorithm that would require a "training set."

9. How the ground truth for the training set was established:

This information is not applicable/provided.

In summary: The provided 510(k) document is a regulatory submission for a physical dental product (sealant) demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, sample sizes, or expert ground truth establishment that would be found in a submission for a novel, AI-driven diagnostic device. The "acceptance criteria" here are implicitly met by demonstrating that the device is "as safe and as effective" as its predicate devices, based on similar indications for use, technological characteristics (materials, physical form, application), and anticipated performance.

Summary

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510(k) Summary Pursuant to 21 CFR 807.92 DEC 2 2 2009

1092019

Submitted By: Enamelite, LLC 1. 1753 B Alpine Drive Clarksville, TN 37040
David C. Furr 2. Contact: FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733 512-906-9654
Enamelite Acryseal Spray Sealant 3. Product: CFR Section 872.3760 Denture relining, repairing, or rebasing resin Class II Product Code: EBI
1. Common/Trade Name:

Enamelite Acryseal Enamelite Acryseal-CB

Description:

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Indications for Use:

Technological Characteristics:

Enamelite Acryseal Spray Sealant is provided in an aerosol can in two formulations. The Acryseal product is provided as an acrylic spray, which is principally composed of Methyl Methacrylate Solids and Monomers; and the Acryseal-CB product is a composite spray, which is principally composed of 2-Methyl-2-Propenoic Acid (1 Methylethylidene) Bis {4,1-Phenyleneoxy (2-Hydroxy-3, 1-propanediyl)} Ester and Triethylene Glycol Dimethacrylate. Barium Oxide filler and Amorphous Silica may be incorporated in the formulation.

The products are supplied in aerosol cans with DYMEL™ Dupont (1,1difluoroethane) propellant. Available sizes are 0.5 oz., 1 oz., 2 oz., and 4 oz. Products supplied in aerosol form do not dry out and change consistency which can happen after opening of brush-on products.

Product is sprayed onto dental fixtures in very light or thin coats. The dental acrylic sealant begins its chemical bonding process as soon as the material hits the surface of the dental fixture. The acrylic sealant can be air cured in 5 minutes and the composite sealant can be light cured in 90 seconds. Spray sealant facilitates a smooth even layer of material when sprayed onto dental fixtures. Surface porosity and any scratches are sealed and smoothed over to a glossy smooth surface to make cleaning easier and help prevent the growth of harmful bacteria.

Substantial Equivalence:

Enamelite Acryseal Acrylic Spray and Enamelite Acryseal-CB Spray are substantially equivalent to Lang Dental Acrylic Primer (K081981), Palaseal (K892452), and Apex Dental Surpass (K061981) .

Each of the devices have similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent.

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Conclusions:

The predicate devices and the Enamelite Acrylic Spray products share similar indications and identical materials of construction. The Enamelite product is equivalent to the predicate device products in all key areas of features and performance that could affect safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 2 2 2009

Enamelite L.L.C. C/O Mr. David C. Furr FDC Services, L.L.C. 8708 Capehart Cove Austin, Texas 78733

Re: K093019

Trade/Device Names: Enamelite Acryseal Spray Sealant and Enamelite Acryseal-CB Spray Sealant Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Codes: EBD and EBI Dated: December 14, 2009 Received: December 16, 2009

Dear Mr. Furr:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III . (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Furr

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

nthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K093019 510(k) Number:

Enamelite Acryseal Spray Sealant Device Name: Enamelite Acryseal-CB Spray Sealant

Indications for Use:

Prescription Use X (per CFR 801.109)

Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rsber DDS for Dr. K.P. Mulry (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093009

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.