(51 days)
Not Found
Not Found
No
The summary describes a dental material (zirconia) for restorations and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a substructure for dental restorations, which is a structural component of a medical device, not a device that directly treats a disease or condition.
No
The 'Intended Use / Indications for Use' states that the device is a "substructure (framework) for a single tooth or bridge type restoration." This indicates a therapeutic or restorative purpose, not a diagnostic one.
No
The 510(k) summary describes a zirconia substructure for dental restorations, which is a physical material/device, 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 a "substructure (framework) for a single tooth or bridge type restoration." This describes a material used in the body for structural support of dental prosthetics.
- Lack of IVD Characteristics: IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any such use or interaction with bodily specimens for diagnostic purposes.
The device is a dental material used for restorative purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
GC - Zirconia is indicated for use as a substructure (framework) for a single tooth or bridge type restoration. Applications include both anterior and posterior locations.
Product codes
EIH
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
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
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The eagle is a simple, abstract design, and the text is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2007
Ms. Terry L. Joritz-Lyons Director - Regulatory Affairs & Quality Assurance GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K071674
Trade/Device Name: GC-Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 01, 2007 Received: June 19, 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. 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 (OS) 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 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/industry/support/index.html.
Sincerely yours,
Chiu, Liu, Ph.D.
Chiu Lin, Ph.D. 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:
GC - Zirconia
Indications for Use:
GC - Zirconia is indicated for use as a substructure (framework) for a single tooth or bridge type restoration. Applications include both anterior and posterior locations.
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)
Suver Russer
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071674
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