(56 days)
Not Found
None
No
The 510(k) summary describes a composite resin material, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
This device is a composite resin used for the aesthetic reproduction of gum on dental prostheses, not for treating or preventing disease or injury.
No
Explanation: The device description states it is a light-cured composite resin used for reproduction of gum on prostheses. This is a material used for fabrication, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "light-cured composite resin," which is a physical material, 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 for the reproduction of gum on crown and bridge prostheses. This is a dental restorative material used in vitro (outside the body) but for creating a physical prosthesis, not for diagnosing a condition or analyzing a biological sample.
- Device Description: It's described as a light-cured composite resin, which is a material used in dental fabrication.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.
Product codes
EBF, EBI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gum on crown and bridge prostheses
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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(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 abstract symbol resembling an eagle or bird with three stylized wings or feathers above three wavy lines, possibly representing water.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 2004
Ms. Terry L. Joritz Director, Regulatory Affairs and Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K033808
Trade/Device Name: GRADIA GUM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBI Dated: December 05, 2003 Received: December 18, 2003
Dear Ms. Joritz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becates wined 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 Interstate conninered pror to that have been reclassified in accordance with the provisions of Amendinents, or to de roos that not is Act (Act) that do not require approval of a premarket the rederal I vod, Drug, and Commay, therefore, market the device, subject to the general approval application (1 the Act. The general controls provisions of the Act include confors provisions of the Fist - 110 Justing 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 If your device is oldsbirou (oos as additional controls. Existing major regulations affecting (1 Mrs), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round ther announcements concerning your device in the Federal Register.
1
Page 2 -- Ms. Terry L. Joritz
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that FDA nas made a determinations administered by other Federal agencies. of the Act of ally I cucial statutes and regarents, including, but not limited to: registration You must comply with an the Fee s requirements (21 CFR Part 801); good manufacturing practice and listing (21 CF R F art 807), labeling 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begil mationing of substantial equivalence of your device to a premits in the results in the PDF mixells in a classification 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), If you desire specific advice for your do research of the Security of county of a contributions on please contact the Office of Complians and access contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (301) 594-4059. "Also, productions 17.97) you may obtain. Other general information on premaired nothbation (2) the Act may be obtained from the Division of Small your responsional 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/dsma/dsmamain.html
Sincerely yours,
Ches
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
2
Indications for Use
510(k) Number (if known): _ K033808
Device Name: GRADIA GUM
Indications for Use:
GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.
Prescription Use
(21 CFR Part 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
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