(90 days)
Not Found
Not Found
No
The description details a dental composite resin and bonding agent, with no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is a composite resin system intended for restoration, core build-up, and post cementation of teeth. While it is used for dental care, it is a material for structural repair rather than a device that provides a therapeutic effect on a disease or condition.
No
Explanation: The device is a dental restorative material (composite resin and bonding agent) used for restoration, core build-up, and post cementation. Its function is to treat or repair, not to diagnose a condition.
No
The device description clearly states it consists of physical components: a composite resin cartridge and a self-etching bonding agent, which are chemical substances and 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 "restoration, core build-up and post cementation" on a "prepared tooth." This describes a direct treatment or repair of a patient's tooth structure.
- Device Description: The device is a composite resin and a bonding agent used to build up or restore tooth material.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue, or other bodily fluids or samples to detect diseases, conditions, or markers.
This device falls under the category of a dental restorative material, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. "GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth. GRADIA CORE is intended to be used for restoration, core build-up and post cementation.
Product codes
EBF
Device Description
GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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 (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 and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, to the right of the text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus. The caduceus is composed of three curved lines that resemble a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori Lappo Regulatory Affairs Assistant GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
OCT 3 0 2008
Re: K082171
Trade/Device Name: GRADIA CORE Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 14, 2008 Received: October 20, 2008
Dear Ms. Lappo:
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 - Ms. Lappo
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 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-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.
Ching-S. Lin, 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
2
Section 5
Indications for Use
510(k) Number (if known):
Device Name: GRADIA CORE
Indications for Use:
GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. "GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth. GRADIA CORE is intended to be used for restoration, core build-up and post cementation.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CURLY Office of Device Evaluation (ODE)
Saber Kumar
(Division Sign-Off) Division of Anesthesiology, Ceneral Hospital Infection Control, Dental Devices
510(k) Number:
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