(55 days)
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No
The summary describes a ceramic material for dental restorations and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a ceramic core used in the manufacture of dental restorations, which is a material component rather than a device intended for therapy.
No
Explanation: The device is described as pellets used in the manufacture of dental restorations, which are therapeutic devices, not diagnostic ones. There is no indication that it is used to diagnose a disease or condition.
No
The device description explicitly states the product is in the form of pellets and is used in the manufacture of dental restorations, indicating a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "used in the manufacture of all-ceramic dental restorations." This describes a material used in a manufacturing process for a medical device (dental restorations), not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is described as "pellets," which aligns with a material used in manufacturing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is used in the manufacture of "all-ceramic dental restorations". The product is in the form of pellets and is processed with currently marketed furnaces.
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
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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.
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Image /page/0/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, stacked on top of each other. To the left of the profiles, the text "DEPARTMENT OF HEALTH &" is arranged vertically, followed by "HUMAN SERVICES" below it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2000
Mr. Andrew J. Pietrobono Operations Manaqer Nev Dental, Incorporated Porcelain Division 1065 S.W. 30th Avenue Deerfield Beach, Florida 33442-8193
K993897 Re : Trade Name: Cerqoqold Regulatory Class: II Product Code: EIH Dated: December 17, 1999 Received: December 20, 1999
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, Druq, 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) requlation (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 requlation may result in requlatory 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
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Page 2 - Mr. Pietrobono
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.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): K993897
Device Name: Cergogold
Indications For Use:
material Ceramic Core This product 1 S used in the manufacture a "all-ceramic dental restorations, The product in the form of pellets and is processed with corrently marketed fornaces
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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OR
Over The -Counter Use
(Optional Format 1-2-96)
Susan Runnes
(Division Sign-Off)
Division of Dental Infection Control