(91 days)
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Not Found
No
The summary describes a traditional dental prosthetic manufacturing technique (ceramic press) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is used to create a porcelain exterior for a dental prosthesis, which is a restorative process, not a therapeutic treatment.
No
The device is described as being "for use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique," which indicates it is used for manufacturing/fabrication, not for diagnosing medical conditions.
No
The provided 510(k) summary describes a device used in prosthetic dentistry for creating the porcelain exterior of a dental prosthesis using a ceramic press technique. This process inherently involves physical materials and techniques, indicating a hardware component (the ceramic press technique itself and the materials used). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique." This describes a process for fabricating a dental restoration, which is a medical device used in the body, not a test performed on a sample taken from the body.
- 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 about a patient's health status
- Using reagents or assays
The device is clearly intended for use in the fabrication of a dental prosthesis, which falls under the category of a medical device used for treatment or restoration, not diagnosis.
N/A
Intended Use / Indications for Use
For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique.
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
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman Collier Shannon Scott 3050 K Street, NW, Suite 400 Washington, DC 20007
Re: K052304
Trade/Device Name: Super Porcelain EX-3 Press Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 22, 2005 Received: November 23, 2005
Dear Ms. Scott:
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 - Mr. Wasserman
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 vour 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" (21CFR 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 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
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Indications for Use
510(k) Number (if known): K052304
Device Name: Super Porcelain EX-3 Press
Indications For Use:
For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis by using ceramic press technique.
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
Ken Meley for MSR
sion of Anesthesiology, General Hospital Infection Control, Den
510(k) Number: