(145 days)
K11270
No
The device description and intended use focus on the material properties and manufacturing process of zirconia discs for dental restorations. There is no mention of AI or ML in the provided text.
No.
The device consists of zirconia discs and dyeing solutions used to fabricate dental restorations, which are not therapeutic in nature.
No
The device description indicates that it consists of machinable zirconia discs and milling blanks used for fabricating dental prostheses, which are restorative rather than diagnostic.
No
The device description clearly states that the device consists of "pre-sintered Zirconia discs" and "visualizer coloring liquid concentrates," which are physical components, not software.
Based on the provided information, the Zenostar MO and Zenostar T devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is for the fabrication of dental restorations (crowns, onlays, bridges). This is a dental material used to create a physical prosthesis, not a diagnostic test performed on a biological sample.
- Device Description: The description confirms they are pre-sintered Zirconia discs used in a CAD/CAM milling process to create dental prostheses. This aligns with a material used for fabrication, not a diagnostic device.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on material properties like flexural strength, chemical solubility, and thermal expansion, which are relevant to the physical performance of a dental restoration, not diagnostic accuracy.
The Zenostar VisualiZr is also not an IVD. It is a temporary dyeing solution for the Zenostar Color Zr solutions, which are themselves materials for dental restorations. Its function is related to the aesthetic properties of the final restoration, not diagnosis.
In summary, these devices are materials used in the creation of dental prostheses, which falls under the category of dental devices rather than IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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 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.
1
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.