(145 days)
Zenostar MO and Zenostar T consist of machinable zirconia discs for the preparation of full ceramic crowns, onlays and bridges (anterior and molar).
Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Zenostar MO (Medium Opacity) are milling discs intended for the fabrication of crown frameworks and multi-unit bridge frameworks for use as dental restorations.
Zenostar T (Translucent) are milling blanks intended for making single-tooth and multiunit restorations for use as dental restorations. Depending on the indication, frameworks or monolithic (full contour) restorations can also be made
Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Zenostar MO and Zenostar T are pre-sintered Zirconia discs with 98.5mm width and various thickness for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. After milling, they are to be sintered at a high temperature to its full density. in order to achieve its expected physical properties. In addition, visualizer coloring liguid concentrates for dyeing Zenostar Color Zr (K11270) Solutions.
The acceptance criteria document provided describes the pre-market notification (510(k)) for dental materials, specifically Zenostar MO, Zenostar T, and Zenostar VisualiZr. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a medical device that usually involves clinical performance metrics like sensitivity, specificity, accuracy, or human interpretability.
Therefore, the following information is extracted based on the nature of this 510(k) submission, which emphasizes material properties and comparison to predicates.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this type of device are primarily compliance with ISO standards for dental ceramic materials and demonstrating equivalence in performance characteristics to the predicate device. The performance is reported in relation to these standards and the predicate.
| Acceptance Criteria (Measured Property) | Reported Device Performance (Zenostar MO/T) | Predicate Device Performance (IPS e.max ZirCAD & Zenotec Zr Bridge, Zenostar Zr Translucent) |
|---|---|---|
| Flexural Strength | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Chemical Solubility | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Coefficient of Thermal Expansion | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Radioactivity | Equivalent to predicate | - (Implied to meet ISO 6872:2008) |
| Biocompatibility | Equivalent to predicate ingredients | - (Implied to have demonstrated biocompatibility) |
| Indications for Use | Substantially equivalent (crowns, onlays, bridges) | Substantially equivalent (crowns, bridges) |
| Chemical Composition | Substantially equivalent | - |
| Technological Characteristics (e.g. delivery form) | Similar (but disc shape vs. block shape, different milling systems) | - |
Note: For "Zenostar VisualiZr", its performance is described as an accessory that "bears no effects on the device or its comparison to the predicate" and that "the liquid burns out almost completely during sintering. Any remaining molecules are bound in the molecular structure of the sintered restoration." This indicates that its performance is assessed by its benign interaction with the primary device.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each physical property test. It mentions that "The device has been designed and tested in accordance with ISO 6872:2008 Dentistry: Ceramic Materials for Flexural Strength, Chemical Solubility, Co-efficient of thermal expansion and Radioactivity." ISO standards typically define the minimum number of samples required for testing.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies. Given this is a BMM (biomaterial) device, the testing would have been conducted in a laboratory setting by the manufacturer (Wieland Dental + Technik Gmbh & Co. Kg).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device submission. The "ground truth" for material properties is established through standardized laboratory testing protocols (e.g., ISO 6872:2008), not through human expert consensus or clinical assessment in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and their disagreements are resolved. For material property testing, the results are quantitative measurements against established standards.
5. 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
This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic devices involving human interpretation of medical images or data. This submission is for dental ceramic materials, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in terms of its properties, is established by standardized laboratory testing and measurements based on international standards (ISO 6872:2008). The expectation is that the material properties meet or exceed the requirements of these standards and are equivalent to the predicate device.
8. The sample size for the training set
This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical material, not a software algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5,2015
Wieland Dental + Technik Gmbh & Co. Kg c/o Ms. Donna Marie Hartnett Director OA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K142233
Trade/Device Name: Zenostar Mo, Zenostar T, Zenostar VisualiZr Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: November 26, 2014 Received: December 5, 2014
Dear Ms. Hartnett,
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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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Susan Runner DDS, MA
Erin Keith Acting 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): K142233
Device Name: Zenostar MO, Zenostar T, Zenostar VisualiZr
Indications For Use:
Zenostar MO and Zenostar T consist of machinable zirconia discs for the preparation of full ceramic crowns, onlays and bridges (anterior and molar).
Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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
Image /page/3/Picture/1 description: The image shows the logo for Wieland Dental. The text "WIELAND" is in large, bold, blue letters. Below that, in smaller blue letters, is the word "DENTAL" with a trademark symbol next to it.
A MEMBER OF THE IVOCLAR VIVADENT GROUP
Contact: Donna Marie Hartnett
Company: lvoclar Vivadent. AG Bendererstrasse 2, Schaan, FL-9494, Liechtenstein +423-235-3535
January 2, 2015 Date Prepared:
Proprietary Name:
Zenostar MO. Zenostar T. Zenostar VisualiZr
Classification Name: Powder, Porcelain (872.6660) (Classification Code EIH)
IPS e.max ZirCAD (K051705) by Ivoclar Vivadent, AG Predicate Device: (Liechtenstein) and Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr, by Wieland Dental (K112710).
Device Description: Zenostar MO and Zenostar T are pre-sintered Zirconia discs with 98.5mm width and various thickness for use in the fabrication of dental prosthesis through the CAD/CAM milling technology. After milling, they are to be sintered at a high temperature to its full density. in order to achieve its expected physical properties. In addition, visualizer coloring liguid concentrates for dyeing Zenostar Color Zr (K11270) Solutions.
Indications for Use:
Zenostar MO and Zenostar T consist of machinable zirconia discs for the preparation of full ceramic crowns, onlays and bridges (anterior and molar). Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Intended Use:
Zenostar MO (Medium Opacity) are milling discs intended for the fabrication of crown frameworks and multi-unit bridge frameworks for use as dental restorations.
Zenostar T (Translucent) are milling blanks intended for making single-tooth and multiunit restorations for use as dental restorations. Depending on the indication, frameworks or monolithic (full contour) restorations can also be made
Zenostar VisualiZr is for the temporary dyeing of Zenostar Color Zr solutions according to the Instructions for Use.
Comparison to Predicate: The predicate device to which Zenostar MO has been compared is IPS e.max ZirCAD (K051705) and Zenostar T and Zenostar VisualiZr have been compared to the predicate Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr, by Wieland Dental (K112710). For this application, Zenostar MO, Zenostar T have been compared to its predicate with regard to chemical composition, performance data and
510K Summary 5-1
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510(K) SUMMARY
Image /page/4/Picture/1 description: The image shows the logo for Wieland Dental. The logo is in blue and features the word "WIELAND" in large, bold letters. Below the word "WIELAND" is the word "DENTAL" in smaller letters. There is a trademark symbol to the right of the word "DENTAL".
A MEMBER OF THE IVOCLAR VIVADENT GROUP indications for use. The comparison shows that Zenostar MO, Zenostar T are substantially equivalent to the predicate device. Zenostar VisualiZr is an accessory only and bears no effects on the device or its comparison to the predicate. The predicate device e.max ZirCAD is available in 1 shade and 1 block size. The subject device is available in 5-7 shares and 7 different disc thicknesses.
The intended use of both Zenostar MO and T are the same. They are used as restorative materials for crowns and bridges. However aesthetic criteria which have to be fulfilled vary depending on the esthetic requirements in the mouth. The availability of Zenostar in two grades of translucency allows the product to be selected which is best suited to the esthetic situation. The physical properties of both products are the same and both MO and T could be used for the identical indications, however due to the esthetic consideration we describe the indications which are most appropriate for each version. The medium opacity material "MO" is most appropriate used as a framework material, which will be covered with a more esthetic layering ceramic. The translucent material "T" is appropriate for monolithic solutions due to the good translucency.
Technological Characteristics: The device design, i.e. delivery form, and intended use of Zenostar MO, Zenostar T and the predicate device are the same. Zenostar VisualiZr bears no effects on the technological characteristics of the device. The predicate device e.max ZirCAD was delivered in block shape for use in the Sirona In-Lab dry CAD/CAM System. The subject device is sold in 98.5mm disc shape for use in the Wieland wet CAM milling system.
Testing Summary: The device has been designed and tested in accordance with ISO 6872:2008 Dentistry: Ceramic Materials for Flexural Strength, Chemical Solubility, Co-efficient of thermal expansion and Radioactivity. The test results are equivalent to those of the predicate device. Biocompatibility data are not submitted because the ingredients of the subject device and the predicate are equivalent. For the VisualiZr Colors, the liquid burns out almost completely during sintering. Any remaining molecules are bound in the molecular structure of the sintered restoration.
CONCLUSION: The above data and analysis demonstrates that Zenostar MO, Zenostar T and Zenostar VisualiZr 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.