(441 days)
"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.
"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.
This document is a 510(k) Premarket Notification from the FDA to Coho Technology Co., Ltd. regarding their "Zibone Zirconia Blocks." The core of the document confirms that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.
The document does not describe a study involving an AI/software device or a diagnostic device, or a study that evaluates human reader performance. Instead, it pertains to a dental material (zirconia blocks) and focuses on demonstrating its physical, chemical, and mechanical equivalence to a predicate device, along with biocompatibility.
Therefore, most of the requested information about acceptance criteria, study design for AI/human reader performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not applicable or cannot be extracted from this document.
However, I can extract the relevant information regarding the device's conformity to standards and the tests performed to establish its equivalence.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance (for a Dental Material, not an AI Device):
The acceptance criteria here are based on meeting the specifications of an international standard for dental ceramics and demonstrating biocompatibility.
| Acceptance Criteria (based on ISO and Biocompatibility Standards) | Reported Device Performance (Summary from Document) |
|---|---|
| Conformance to ISO 6872:2008 (Dentistry - Ceramic materials) | "The material conforms to international standard ISO 6872:2008 Dentistry - Ceramic materials to guarantee biocompatibility and necessary mechanical strength." "tests per ISO 6872 validated the equivalence of these two devices and ensured that the subject device is suitable for its indications." Tested for: Thermal expansion, chemical solubility, 4-point bending strength, and radiation tests per ISO 6872. |
| Biocompatibility | Biocompatibility evaluations performed: - Cytotoxicity per ISO 10993-5 and ISO 10993-11 - Sensitization and irritation per ISO 10993-10 - Pyrogen tests per ISO 10993-11 and USP 151 Results: "favorable biocompatibility results" |
| Substantial Equivalence to Predicate Device (K100145) | "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." Key similarities highlighted: Same major chemical component (ZrO2), similar indications for use, similar method of fabrication (CAD/CAM Systems), similar types of restorations, and same device forming process (Press CIP). Differences in percentages of chemical composition were noted but deemed equivalent based on ISO 6872 testing. |
Information NOT Applicable to this Document (as it's not an AI/Software/Diagnostic Device Study):
- Sample sizes used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical materials, not a digital dataset or patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a material's physical properties is established through standardized laboratory testing, not expert consensus on images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for diagnostic studies, not material testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic device studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is the established specifications and performance parameters outlined by ISO 6872:2008 and other biocompatibility standards (e.g., ISO 10993 series, USP 151), validated through laboratory bench testing.
- The sample size for the training set: Not applicable. This is for machine learning models.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory approval for a dental material based on its physical, chemical, and mechanical properties and biocompatibility, not a performance study for an AI-powered diagnostic tool.
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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.
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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
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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.
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| Subject Device (K140836) | Predicate Device (K100145) | |
|---|---|---|
| Major chemicalcomponent | ZrO2 | ZrO2 |
| Indications for Use | "Zibone Zirconia Blocks" areintended for CAD/CAMfabrication of full ceramicdental restorations such ascopings, crowns, inlays,onlays, veneers, andbridges of 3 or less units. | "A&E zirconia blanks are pre-sintered metal-free zro2 ceramicblanks (y-tzp). They arespecifically designed forfabrication of sub-frames for theconstruction of dental prosthetic(e.g, crowns and bridgesrestorations etc) with the aid ofmanual copy-milling machinesand cad/cam systems |
| Method of fabrication | CAD/CAM Systems | CAD/CAM Systems and manualmilling 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 becustomized during sintering | White/ Color can be customizedduring sintering |
| Device FormingProcess | 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.
§ 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.