(54 days)
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Not Found
No
The summary describes a ceramic blank for dental restorations and mentions CAD/CAM techniques, but there is no mention of AI or ML in the device description, intended use, or other sections.
No.
The device is a ceramic blank used to manufacture dental restorations; it does not directly treat or diagnose a condition.
No
Explanation: The device is a ceramic blank used for manufacturing dental restorations, not for diagnosing medical conditions.
No
The device is a physical ceramic blank used for manufacturing dental restorations, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for manufacturing dental restorations (crowns and bridges) for patient-specific tooth/bridge specifications. This is a manufacturing process for a medical device that will be implanted or placed in the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a ceramic blank, which is a raw material for creating a dental restoration.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
ZIECON® Zirconia Ceramic Blanks are designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques & MOM for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner.
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
patient-specific anterior/posterior tooth/bridge
Indicated Patient Age Range
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Intended User / Care Setting
customers/dental laboratories, dental practitioner
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Raju Merani Technical Director Jyoti Ceramic Industries PVT, LTD C-21, NICE, Satpur, Nashik-422 007 Maharashtra INDIA
OCT 2 7 2010
Re: K102538
Trade/Device Name: ZIECON® Zirconia Ceramic Dental Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 15, 2010 Received: September 3, 2010
Dear Mr. Merani:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2- Mr. Merani
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use
12102538
OCT 27 2010
510(K) Number (if Known) :
Device Name
: ZIECON® Zirconia Ceramic Dental Blanks.
Indication for Use
ZIECON® Zirconia Ceramic Blanks are designed for 4 manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques & MOM for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner.
Prescription Use: X (Part 21 CFR 801 Subpart D)
AND/OR Over the Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:
uation (ODE)
Susan Runne
(Division Sign-ni) Division of Anesthesiology, General Hospital infection Control, Dental Devices
.3(k) Number: k-toa53f