(76 days)
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Not Found
No
The device description and intended use clearly indicate it is a dental restorative material (resin), with no mention of AI or ML capabilities.
No
The device is a restorative material used for dental fillings and repairs, primarily addressing structural and aesthetic issues of teeth rather than treating a disease or promoting healing in a broad therapeutic sense.
No
The device is described as a "visible light-cured micro-filled hybrid resin" used for direct restorative purposes for various types of cavities and dental issues. This indicates it is a therapeutic or restorative device, not one designed for diagnosis.
No
The device description clearly states it is a "visible light-cured micro-filled hybrid resin," which is a physical material used in dental restorations, 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 direct restorative procedures on teeth (filling cavities, veneers, etc.). This is a direct treatment applied to the patient's body.
- Device Description: The device is a "visible light-cured micro-filled hybrid resin," which is a material used for dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body to repair or restore teeth.
N/A
Intended Use / Indications for Use
GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:
GRADIA DIRECT ANTERIOR:
- Direct restorative for Class III, IV and V cavities.
- Direct restorative for wedge-shaped defects and root surface cavities.
- Direct restorative for veneers and diastema closure.
GRADIA DIRECT POSTERIOR:
- Direct restorations for Class I and II cavities.
Product codes (comma separated list FDA assigned to the subject device)
76 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, representing health and well-being. The figure is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2003
·Mr. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K023814
Trade/Device Name: Gradia Direct Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: 76 EBF Dated: November 11, 2002 Received: November 15, 2002
Dear Mr. Joritz:
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.
1
Page 2 - Mr. Joritz
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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runner
Susan Runner, DDS, MA Interim 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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16 2 3 814 510(k) Number (if known):
Device Name:_ Gradia_Direct__
Indications For Use:
GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:
GRADIA DIRECT ANTERIOR:
-
- Direct restorative for Class III, IV and V cavities.
-
- Direct restorative for wedge-shaped defects and root surface cavities.
-
- Direct restorative for veneers and diastema closure.
GRADIA DIRECT POSTERIOR:
-
- Direct restorations for Class I and II cavities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
- Direct restorations for Class I and II cavities.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Formal 1 -: -96)
Kevin Muluy for MSR
(Division Sign-Off) (Division Sign-off)
Division of Anesthesiology, General Hospital, Division of Antol, Dental Devices
510(k) Number: K023814