(72 days)
Not Found
Not Found
No
The summary describes a porcelain material and accessories for creating dental prostheses, with no mention of software, image processing, or AI/ML terms.
No
The device, "Super Porcelain TI-22 and Accessories," is used to create a porcelain prosthesis, which is a restorative material used in dentistry, not a therapeutic device designed for treating a disease or condition.
No
Explanation: The device description states it is used to "create a porcelain prosthesis," which is a manufacturing or restorative function, not a diagnostic one.
No
The summary describes a physical material (Super Porcelain TI-22) and accessories used in prosthetic dentistry, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium." This describes a device used in the mouth to create a dental restoration.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease or conditions.
This device is used directly in the process of creating a dental prosthesis, not for analyzing biological specimens outside the body. It's a material and associated accessories used in a dental laboratory or clinic setting for fabrication.
N/A
Intended Use / Indications for Use
For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.
Product codes (comma separated list FDA assigned to the subject device)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line. The text is black against a white background.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Noritake Company, Incorporated C/O Ms. Marsha C. Wertzberger Counsel for Noritake Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, N.W. Washington, DC 20036-5339
Re : K992024 Super Porcelain TI-22 Trade Name: Regulatory Class: II Product Code: EIH Dated: June 15, 1999 Received: June 16, 1999
Dear Ms. Wertzberger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Ms. Wertzberger
through 542 of the Act for devices under the Electronic chrough 312 or cho introl provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Info ibed in your 510 (k) premarket notification. The FDA deboring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markees 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known) __
Device Name: Super Porcelain TI-22 and Accessories
Indications For Use:
ノ『
For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Susan Runns
(Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control,
Division of Devices Division... Hospital D evices 16 510(k) Number
Prescription Use
(Per 21 CFR 801.109)