(84 days)
Not Found
No
The device description and intended use focus on the chemical composition and application method of a dental sealant, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and dental restorations, which are structural components and not for treating diseases or conditions.
No
Explanation: The device description states its purpose is to "reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations." This indicates a therapeutic or restorative function, not a diagnostic one. It functions similarly to existing brush-on sealants for surface finishing, rather than identifying or characterizing a medical condition.
No
The device description clearly states it is a dental sealant or bonding agent packaged for aerosol dispensing, 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 "reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations." This describes a product used on dental devices (dentures and restorations) for physical repair and sealing, not for testing or analyzing biological samples from the human body.
- Device Description: The description reinforces this by stating it's a "dental sealant or bonding agent" and comparing it to "brush on sealants" used in the dental profession.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease or condition, or providing information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is purely related to the physical maintenance and repair of dental prosthetics.
N/A
Intended Use / Indications for Use
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.
Product codes
EBI, EBD
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
-
- Common/Trade Name:
Enamelite Acryseal Enamelite Acryseal-CB
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.
1
Indications for Use:
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.
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.
2
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.
3
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.
4
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
5
Indications for Use Statement
K093019 510(k) Number:
Enamelite Acryseal Spray Sealant Device Name: Enamelite Acryseal-CB Spray Sealant
Indications for Use:
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.
Prescription Use X (per CFR 801.109)
or
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