(13 days)
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No
The summary provides no information suggesting the use of AI or ML. The intended use describes a material for CAD/CAM fabrication, which is a standard manufacturing process.
No.
The document states that the device is intended for the "fabrication of zirconia frameworks for all-ceramic dental restorations," which describes a material used in restorative dentistry rather than a device that directly treats a disease or condition.
No
The intended use statement indicates that KATANA Zirconia is for the fabrication of frameworks for dental restorations, rather than for identifying or detecting a disease or condition.
No
The intended use describes a material (zirconia) for CAD/CAM fabrication of dental restorations, which is a physical component, not software. The summary lacks information about any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations." This describes a process for creating a physical dental product, not a test performed on biological samples to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Measurement of analytes or biomarkers
Therefore, KATANA Zirconia, as described, falls under the category of a dental material used in the fabrication of restorations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.
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
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Key Metrics
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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
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§ 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle symbol, which is the logo for the U.S. Department of Health and Human Services. The eagle is depicted with three curved lines representing its wings and body. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 7 2005
Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman, Counsel Collier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K Street NW Washington, District of Columbia 20007
Re: K050160
Trade/Device Name: Katana Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 24, 2005 Received: January 25, 2005
Dear Mr. Wasserman:
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. Ivan J. Wasserman, Esq.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a substance equires with other requirements of the Act or that FDA has made a determination inal your device real sencies. You must comply with any Federal statures and regulations administered by out registrations and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: get forth in all the Act's requirements, including, but normance to: requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as set f labeling (21 CFR Part 801), good manufacturing production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produc systems (QS) regulation (2) -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)
The same of the same of the collection of the mixelesses of your device to legal This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial end the permits your premarket notification. The FDA finding of substanter of 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
r the receific advice for your 171, 2115 - the received as a prouletion ent If you desire specific advice for your ac not of the Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the may contact the Office of Compliance at (2-0) 276 of 101.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Division of Small " Misbranding by reference to premailities under the Act from the Division of Small general information on your responsibilities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-freenumbin html Manufacturers, International and Consumer Pisessuates agov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu S. Lin, PhD 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): Ќ050| 60
Device Name: KATANA Zirconia
Indications For Use:
KATANA Zirconia is intended for CAD/CAM fabrication of zirconia frameworks for allceramic dental restorations.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Susan Rumer
KOSOIL
raston Sign-Off) ിച്ച് വിട്ടിക്കാന വിട്ടു. General Hospital, Intection Control, Dental Devices
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