(87 days)
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No
The summary provides no information suggesting the use of AI or ML; it describes a material for dental restorations.
No
The device, KATANA Zirconia, is used for fabricating dental restorations, which are prosthetic devices used to replace or restore parts of teeth. It is a material for manufacturing, not a device that directly treats a condition or disease.
No
The device, KATANA Zirconia, is used for the fabrication of dental restorations (frameworks, crowns, bridges, inlays, onlays, and veneers). It does not appear to primarily identify or determine the nature of a disease or condition.
No
The intended use describes the fabrication of physical dental restorations (frameworks, crowns, bridges, etc.) from Zirconia. This implies a manufacturing process involving physical materials and potentially hardware, not solely software. The lack of a device description further prevents confirmation of a software-only nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that KATANA Zirconia is used for the fabrication of dental restorations (frameworks, crowns, bridges, inlays, onlays, and veneers). This is a manufacturing process for medical devices that are implanted or placed in the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Being used in a laboratory setting
Therefore, based solely on the provided text, KATANA Zirconia falls under the category of a dental material used for fabrication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KATANA Zirconia is used for the fabrication of the all-ceramic restorations (frameworks, FCZ crowns, FCZ bridges, inlays, onlays and veneers).
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
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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)
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Reference Device(s)
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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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines that suggest a profile view of a person's head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27,2015
Kuraray Noritake Dental Inc. Michio Takigawa Manager Ote Center Bldg. 7F. 1-1-3, Otemachi, Chiyoda, 1000004 Tokyo. Janan
Re: K143439
Trade/Device Name: KATANA Zirconia Regulation Number: 21 CFR 872.6600 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: December 01, 2014 Received: December 02, 2014
Dear Michio Takigawa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno, DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K143439
Device Name: KATANA Zirconia
Indications for Use:
KATANA Zirconia is used for the fabrication of the all-ceramic restorations (frameworks, FCZ crowns, FCZ bridges, inlays, onlays and veneers).
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)