(85 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a traditional dental prosthesis creation process.
No
The device is used to create a prosthesis, which is a restorative device and not primarily for treating a disease or condition.
No
The device is described as being used "TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY," which indicates it is for manufacturing or restorative purposes, not for diagnosing a condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use suggests a physical prosthesis is created, which would typically involve hardware.
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 DENTAL ALLOY". This describes a process for creating a dental restoration, which is a physical device used in the mouth.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. The provided description does not mention any such activity or the analysis of biological samples.
Therefore, this device falls under the category of a dental prosthetic or material used in the creation of a dental prosthetic, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY.
Product codes
EIH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figures. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 30 1998
Noritake Company, Incorporated C/o Ms. Marsha C. Wertzberger Counsel for Noritake Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, NW Washington, DC 20036-5339
Re : K982766 Paste Opaque EX-3 Trade Name: Requlatory Class: II Product Code: EIH August 6, 1998 Dated: Received: August 6, 1998
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 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 qeneral 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Ms. Wertzberger
This letter will allow you to begin marketing your device as described in your 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 requlation (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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.fday.gov/cdrh/dsmamain.html".
Sincerely yours
y A. Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
510(k) Nunber (if known): __
FASTE OPAQUE EX-3 Device Name: __
Indications For Use:
)
FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBODED)
Concerrence of CDRH. Office of Device Evaluation (GDB)
Sines Ruanes
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices K9827101 510(k) Number
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
ﺘﻲ ﺇﻧ
02/13 '96 11:07