(441 days)
Not Found
No
The summary describes a material (zirconia blocks) used in CAD/CAM fabrication, but does not mention any AI/ML components within the blocks or the fabrication process itself. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a material (zirconia blocks) used to fabricate dental restorations, not a therapeutic device that directly treats or prevents a disease or condition. Its function is to be milled into products that then serve a restorative purpose.
No
The device is described as "Zibone Zirconia Blocks" intended for CAD/CAM fabrication of dental restorations. Its purpose is to construct physical dental prosthetics, not to diagnose medical conditions or diseases.
No
The device is a physical material (zirconia blocks) intended for fabrication of dental restorations using CAD/CAM technology. The description focuses on the material properties and physical form of the blocks, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the CAD/CAM fabrication of dental restorations. This is a manufacturing process for creating physical dental prosthetics.
- Device Description: The device is a material (zirconia blocks) used in this fabrication process.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body for diagnostic purposes.
IVD devices are typically used to perform tests on samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical restoration, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
"Zibone Zirconia Blocks" are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.
Product codes
EIH
Device Description
"Zibone Zirconia Blocks" are made from partially sintered zirconium oxide. The devices are to be CNC machined to construct dental restorations and substructures such as crowns and bridges with the aid of CAD/CAM technology.
The devices are in cylinder forms with a constant diameter of 98mm and variety of heights from 12 to 20 mm, and in rectangular bar forms with various lengths and widths with the height of 16mm.
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
The devices have been tested for its physical, chemical and mechanical properties such as thermal expansion, chemical solubility, 4-point bending strength, and radiation tests per ISO 6872, in addition to the biocompatibility evaluations such as cytotoxicity per ISO 10993-5 and ISO 10993-11, sensitization and irritation per ISO 10993-10, and pyrogen tests per ISO 10993-11 and USP 151.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Coho Technology Co., Ltd. Ms. Jacky Hsieh General Manager 21 Dafeng Street Luju Township, Taoyuan County 33860 Taiwan
Re: K140836 Trade/Device Name: Zibone Zirconia Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 10, 2015 Received: April 22, 2015
Dear Ms. Hsieh:
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 - Ms. Jacky Hsieh
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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):_ K140836
Device Name: Zibone Zirconia Blocks
Indications for use:
"Zibone Zirconia Blocks" are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.
V Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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510 (K) Summary
This summary of 510(K) substantial equivalence information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92
1. Submitter:
Coho Technology Co., Ltd Contact Name: Jacky Hsieh Address: No.21 Dafeng St, Luju Township, Taoyuan Countv. Taiwan R.O.C 33860 Email:jackyhsieh@coho.com.tw Tel: +886-3- 3112203 Fax: +886-3-3125626
2. Summary Preparation Date: Feb 14, 2014
3. Device Identification:
| Trade name: | Zibone Zirconia Blocks |
|---|---|
| Classification Name | Porcelain powder for clinical use |
| Common name: | Zirconia Blanks/Blocks |
| Product code: | EIH |
| Regulation No.: | 21CFR 872.6660 |
| Classification: | Class II |
4. Legally marketed equivalent device:
A&E Zirconia Blanks 510 (K) number: K100145
5. Device Description:
"Zibone Zirconia Blocks" are made from partially sintered zirconium oxide. The devices are to be CNC machined to construct dental restorations and substructures such as crowns and bridges with the aid of CAD/CAM technology.
The devices are in cylinder forms with a constant diameter of 98mm and variety of heights from 12 to 20 mm, and in rectangular bar forms with various lengths and widths with the height of 16mm.
6. Intended Use:
"Zibone Zirconia Blocks" are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.
7. Technological characteristics:
"Zibone Zirconia Blocks" and the predicate device have the same intended use and are made from the same zirconium oxide material. Furthermore, the material conforms to international standard ISO 6872:2008 Dentistry - Ceramic materials to guarantee biocompatibility and necessary mechanical strength.
4
| Subject Device (K140836) | Predicate Device (K100145) | |
|---|---|---|
| Major chemical | ||
| component | ZrO2 | ZrO2 |
| Indications for Use | "Zibone Zirconia Blocks" are | |
| intended for CAD/CAM | ||
| fabrication of full ceramic | ||
| dental restorations such as | ||
| copings, crowns, inlays, | ||
| onlays, veneers, and | ||
| bridges of 3 or less units. | "A&E zirconia blanks are pre- | |
| sintered metal-free zro2 ceramic | ||
| blanks (y-tzp). They are | ||
| specifically designed for | ||
| fabrication of sub-frames for the | ||
| construction of dental prosthetic | ||
| (e.g, crowns and bridges | ||
| restorations etc) with the aid of | ||
| manual copy-milling machines | ||
| and cad/cam systems | ||
| Method of fabrication | CAD/CAM Systems | CAD/CAM Systems and manual |
| milling machines | ||
| Shape | Cylinder and Bar shapes | Cylinder |
| Types of restorations | Coping/Crown/Inlay/Onlay/ | |
| Veneer/Bridge | Coping/Crown/Inlay/Onlay/ | |
| Veneer/Bridge | ||
| Colors | White/ Color can be | |
| customized during sintering | White/ Color can be customized | |
| during sintering | ||
| Device Forming | ||
| Process | Press (CIP) | Press (CIP) |
The subject device and predicate device although are different in the percentage of their chemical compositions, but the major components are identical. Furthermore, tests per ISO 6872 validated the equivalence of these two devices and ensured that the subject device is suitable for its indications.
8. Non-Clinical Bench Tests:
The devices have been tested for its physical, chemical and mechanical properties such as thermal expansion, chemical solubility, 4-point bending strength, and radiation tests per ISO 6872, in addition to the biocompatibility evaluations such as cytotoxicity per ISO 10993-5 and ISO 10993-11, sensitization and irritation per ISO 10993-10, and pyrogen tests per ISO 10993-11 and USP 151.
9. Conclusion:
Based on similar chemical composition, intended use, technological characteristics, physical properties testing, and favorable biocompatibility results, Zibone Zirconia Blocks are substantially equivalent to the predicate device.