(21 days)
Not Found
Not Found
No
The 510(k) summary describes a dental porcelain material, not a software or imaging device, and there are no mentions of AI or ML.
No
The device is described as "DENTAL PORCELAIN DESIGNED FOR USE IN THE MANUFACTURE OF PORCELAIN FUSED TO METAL RESTORATION," indicating it is a material for manufacturing dental restorations, not a device that directly provides therapy or treatment to a patient.
No
Explanation: The intended use of the device is for the manufacture of dental restorations, which is a manufacturing process, not a diagnostic one. It does not mention identifying, detecting, or measuring a disease or condition.
No
The provided 510(k) summary describes a dental porcelain material, which is a physical substance used in manufacturing, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "DENTAL PORCELAIN DESIGNED FOR USE IN THE MANUFACTURE OF PORCELAIN FUSED TO METAL RESTORATION." This describes a material used in the creation of a dental prosthetic, which is a medical device, but not an IVD.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of this dental porcelain does not involve any such activity.
Therefore, this device falls under the category of a dental material used in the manufacturing of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DENTAL PORCELAIN DESIGNED FOR USE IN THE MANUFACTURE OF PORCELAIN FUSED TO METAL RESTORATION.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1999
Mr. Andrew J. Pietrobono Manufacturing Engineer, Quality Manager, and Official Correspondent Ney Dental, Incorporated Porcelain Division 1065 S.W. 30th Avenue Deerfield Beach, Florida 33442-8193
K990629 Re : Trade Name: SYMBIOceram Regulatory Class: II Product Code: EIH February 17, 1999 Dated: February 26, 1999 Received:
Dear Mr. Pietrobono
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 general controls provisions The general controls provisions of the Act 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. A 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 Drug 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
1
Page 2 - Mr. Pietrobono
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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" (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) 638f2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.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): | K990629 |
|---|---|
| Device Name: | EXCELSTONE PORCELAIN |
| SYMBIOCERAM | |
| Indications For Use: | DENTAL PORCELAIN DESIGNED FOR USE |
| IN THE MANUFACTURE OF PORCELAIN FUSED | |
| TO METAL RESTORATION. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
susgin unto (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices chacles 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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