(42 days)
Not Found
Not Found
No
The summary provides no information about the device's internal workings, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML-powered medical devices. The intended use is purely related to sealing dental restorations.
No
The device is described as sealing the surface of dental restorations, which is a restorative or protective function, not a therapeutic one aimed at treating a disease or condition.
No
The Intended Use describes sealing restorations, which is a treatment or protective function, not a diagnostic one.
No
The 510(k) summary describes a device intended to seal dental restorations, which is a physical process involving a material applied to a surface. This indicates a hardware component (the sealant material) is involved, not just 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 "seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin." This describes a material used in vivo (within the body) to seal dental restorations.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens.
Therefore, this device falls under the category of a dental material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.
Product codes
EBD
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three horizontal bars extending from its wing, representing the department's mission to protect the health of all Americans and provide essential human services.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Terry L. Joritz-Lyons Director - Customer Care Group GC America, Inc. 3737 West 127th Street Alsip, Illinois 60803
Re: K052462
Trade/Device Name: G-Coat Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: August 19, 2005 Received: September 12, 2005
Dear Ms. Joritz-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 510(t) production is substantially equivalent (for the indications for referenced above and nave acternillied are e devices marketed in interstate commerce use stated in the encrosure) to regally man of the Medical Device Amendments, or to devices that proof to May 26, 1970, fire chaolinens and the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance was a proval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, sabject erequirements for annual registration, listing of devices, good Controls provisions of the reville, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (360 above) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish fourther announcements concerning your device in the Federal Register
1
Page 2 - Ms. Terry L. Joritz-Lyons
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r touse of advisod that I 27 rination that your device complies with other requirements of the Act or that I Drived a accessions administered by other Federal agencies. You must comply with all 1 caeral surface and regarding, but not limited to: registration and listing (21 CFR Part 807); an the Ave requirements as a manufacturing practice requirements as set forth in the quality laboring (21 CFR Part 800); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter wiff anow your to ough finding of substantial equivalence of your device to a legally prematicated predicated. - The slassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other IMisoranding of televisibilities under the Act from the Division of Small general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susa Kunor
Zita S. Luki, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: G-Coat
Indications For Use:
To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Conner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K052462
Prescription Use
(Per 21 CFR 801.109 ✓
OR
Over-The-Counter Use ----------
(Optional Format 1-2-96)