(136 days)
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Not Found
No
The summary provides no information about the device's internal workings or technology, and there are no mentions of AI, ML, or related terms. The intended use is purely mechanical/material processing.
No
The device is used to create porcelain prostheses, which are replacements for missing teeth, not for treating diseases or conditions.
No
Explanation: The device description states its use is to "create porcelain (ceramic) prostheses," which is a treatment or restorative function, not a diagnostic one.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the Zirkondent is a software-only medical device or includes hardware components.
Based on the provided information, the Zirkondent is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to create porcelain (ceramic) prostheses" for use in prosthetic dentistry. This describes a device used to manufacture a medical device (a prosthesis), not a device used to perform tests on samples taken from the human body to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring biomarkers or analytes
The Zirkondent appears to be a manufacturing or processing device used in a dental laboratory or clinic to produce dental prosthetics.
N/A
Intended Use / Indications for Use
The Zirkondent is indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses.
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
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 Department of Health & Human Services - USA. The logo consists of a circular arrangement of text surrounding a stylized image of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The eagle is depicted with its wings spread, and its head turned to the left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2008
Mr. Michael Artemov Vice President Business Development ERGOMETA 144 Los Flores Aliso Viejo, California 92656
Re: K080146
Trade/Device Name: Zirkondent Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 22, 2008 Received: May 23, 2008
Dear Mr. Artemov:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Artemov
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syrite Y. Michie Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K080146
Device Name: Zirkondent
Indications for Use:
The Zirkondent is indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses.
Prescription Use x (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punoer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K050616
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