(49 days)
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No
The 510(k) summary describes a dental composite resin, which is a material, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The device, a light-cured micro-filled composite resin, is intended for direct restorative use in Class I and II cavities, which involves treating a disease state (cavities) and restoring normal function.
No
Explanation: The intended use states that the product is a "light-cured micro-filled composite resin for use in the following recommended indications: Direct restorative for Class I and II cavities." This describes a material used for treatment (filling cavities), not for diagnosing a condition.
No
The device is described as a "light-cured micro-filled composite resin," which is a physical material used in dentistry, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Direct restorative for Class I and II cavities." This describes a material used directly on a patient's teeth for filling cavities.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The provided description clearly indicates a material used for dental restoration within the body, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
This product is a light-cured micro-filled composite resin for use in the following recommended indications: Direct restorative for Class I and II cavities.
Product codes
EBF
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry L. Joritz-Lyons Director - Regulatory Affairs and Quality Assurance GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
MAR I 2 2007
Re: K070190
Trade/Device Name: Gradia Direct X Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 10, 2007 Received: January 26, 2007
Dear Ms. Joritz-Lyons:
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 such 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 - Ms. Terry L. Joritz-Lyons
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,
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
Indications for Use
510(k) Number (if known): _
Device Name:
Indications for Use:
1070190
Gradia Direct X
This product is a light-cured micro-filled composite resin for use in the following recommended indications:
Direct restorative for Class I and II cavities.
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)
Syron Runne
THE NEW YORK TIMES
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