(77 days)
Not Found
No
The description focuses on the material properties and intended use of a dental blank, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a dental material used to fabricate crowns and bridges, which are prosthetics and not therapeutic devices.
No
Explanation: The device is a "Zirconia Blank" used for the production of dental prostheses (crowns, bridges, etc.) and is described as a "dental material." It is not described as detecting, identifying, or characterizing a disease or condition for the purpose of diagnosis.
No
The device is a physical dental material (zirconia blanks) used in the production of crowns and bridges, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Zirconia Blanks are dental materials used for creating crowns, bridges, and other dental prostheses. These are implanted or placed in the mouth, not used to test bodily fluids or tissues in vitro.
- The description focuses on the material properties and manufacturing process for dental restorations. There is no mention of analyzing biological samples or providing diagnostic information about a patient's health condition.
Therefore, this device falls under the category of a dental material or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Product codes
EIH
Device Description
Zirconia Blanks are dental materials (semi finished products) made of presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or hand operated copymilling machines, with outstanding biocompatibility and high resistance against tension and pressure.
In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing, Material analysis and biocompatibility tests were performed by third party laboratories. The device passed all tests.
Kerox Ltd. did not conduct clinical tests to determine substantial equivalence.
Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Exhibit #1
510(K) SUMMARY
JUN - 6 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date Prepared: March 16, 2012
-
- Applicant: Mr. Fényi Balázs Kerox Ltd. H-2049 Diosd, Homokbanya ut 77. Hungary
Phone: (36 23) 382 006, ext-105
- Applicant: Mr. Fényi Balázs Kerox Ltd. H-2049 Diosd, Homokbanya ut 77. Hungary
Fax: 36 23 545 158 EMAIL: balazs.fenyi@keroxdental.net
2. Submitter:
Mr. Sangram Yadav Official Correspondent for Kerox Ltd mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
TEL: 516-482-9001 FAX: 516-482-0186
EMAIL:sangram@mdiconsultants.com
Name of the Device: 3.
Zircostar (zirconia blanks)
Common or Usual Name and Classification: 4.
1
Porcelain powder for clinical use. Regulation number: 872.6660 Product Code EIH
Predicate Device Information: ડ.
Dental Direct DD Bio Z, DD Bio Z-transpa 510k number: (K093748)
Device Description : 6.
Zirconia Blanks are dental materials (semi finished products) made of presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or hand operated copymilling machines, with outstanding biocompatibility and high resistance against tension and pressure.
In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.
7. Intended Use
Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges Applications include both anterior and posterior bridges.
Comparison to Predicate Devices: 8.
The Zircostar (Zirconia blank) is substantially equivalent to the Dental Direct DD Bio Z, DD Bio Z-transpa the predicate device in intended use, operation, safety and function.
-
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
2
Mechanical testing, Material analysis and biocompatibility tests were performed by third party laboratories. The device passed all tests.
10. Clinical Testing:
Kerox Ltd. did not conduct clinical tests to determine substantial equivalence.
11. Non Clinical Testing:
Kerox dental did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008.
Risk Management:
The device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous
Application of a risk management program according to ISO 14971 "Medical devices - Application of risk management to medical devices".
Technological characteristics:
The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They have the same intended use.
· 12. Conclusion:
Kerox Ltd believes that Zircostar (Zirconia blank) is as safe and effective as the predicate device when used as instructed by knowledgeable and trained personnel, and are substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 6 2012
Kerox Limited C/O Mr. Sangram Yadav Official Correspondent MDI Consultants. Incorporated 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K120852
Trade/Device Names: Zircostar Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 30, 2012 Received: May 31, 2012
Dear Mr. Yadav:
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 Eederal Register.
4
Page 2 - Mr. Yadav:
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 (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.
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
5
Indications for Use
K120852
510(k) Number (if known):
Device Name: Zirconia Blanks (Zircostar)
Indications for Use:
Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
AND/OR Prescription Use X (Per 21CFR 801 Subpart D)
Over-The-Counter Use (21CFR 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 Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120852