(81 days)
Not Found
Not Found
No
The 510(k) summary describes a dental composite resin, a material used for fillings. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The description focuses solely on the material properties and delivery systems.
No
The device is a composite resin for restoration, which is a dental material used for repair, not a therapeutic device designed for treating diseases or disorders.
No
The device is a composite resin used for restoration of teeth, not for diagnosis.
No
The device description clearly states it is a "light-cured micro-filled radiopaque 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 "restoration of both anterior and posterior teeth." This is a direct treatment or repair of a physical structure within the body.
- Device Description: The device is a "light-cured micro-filled radiopaque composite resin." This is a material used for filling cavities and restoring tooth structure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to gain information about a patient's health status. This device is a restorative material used directly on the patient's teeth.
N/A
Intended Use / Indications for Use
GDLS is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.
Product codes
EBF
Device Description
GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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 stylized eagle with three stripes forming its body and wing. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
NOV 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Mark Heiss Director, Professional Relations & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K082434
Trade/Device Name: GDLS-200 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 20, 2008 Received: August 25, 2008
Dear Dr. Heiss:
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 - Dr. Heiss
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 procced to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Thi S. Uyen, Ph.D.
Chiu S. Lin. Ph. D Division 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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Section 5 -- Indications for Use Statement
Indications for Use
510(k) Number (if known): 5082434
Device Name: GDLS-200
Indications for Use:
GDLS is a light-cured micro-filled radiopaque composite resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip (capsules for single dose) and Syringes. The GDLS-20() systems is available in a variety of shades.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OFF
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082434
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