(82 days)
Not Found
Not Found
No
The summary describes a dental porcelain stain, a material used in prosthetic dentistry, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a porcelain stain used to create a porcelain prosthesis, which is a material used in dentistry, not a therapeutic device for direct treatment or amelioration of a disease or condition.
No
The device is described as "SUPER PORCELAIN STAIN - PURE WHITE" and is used to "CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY." This indicates it is a material used in the creation of a dental prosthesis, not a tool or system used to diagnose a condition.
No
The device description "SUPER PORCELAIN STAIN - PURE WHITE" strongly suggests a physical material 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 DENTAL ALLOY". This describes a material used in the fabrication of a dental restoration, not a test performed on a sample taken from the human body to provide information about a physiological or pathological state.
- Device Description: "SUPER PORCELAIN STAIN - PURE WHITE" further reinforces that this is a material used in the dental lab.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, providing diagnostic information, or any of the typical elements associated with IVD devices (e.g., reagents, calibrators, controls, analytical performance metrics).
Therefore, this device falls under the category of a dental material used in the fabrication of a prosthesis, 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/2 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 an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1998
Noritake Company, Incorporated
C/O Ms. Marsha C. Wertzberger Counsel for Noritake Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, N.W. 20036-5339 Washington, DC
Re : K983470 Super Porcelain Stain - Pure white Trade Name: Requlatory Class: II Product Code: EIH October 1, 1998 Dated: Received: October 1, 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 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. ਕੇ 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 Siz or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your and equivalence of your device to a legally marketed predicate device results in a classification for your marketed predices with 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 regulation 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/dsmamafin.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
510(k) Number (if known):
SUPER PORCELAIN STAIN - PURE WHITE 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 NEEDED)
CDRH. Office of Device B ion (ODE)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 168 3470 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use
(Options) Formal 1-2-96)
02/13 '96 11:07