(127 days)
Not Found
No
The summary describes zirconia blocks for dental restorations and does not mention any AI or ML components or functionalities.
No.
The device is a material (yttria-stabilized zirconia) used for manufacturing dental restorations like crowns, bridges, inlays, onlays, and veneers, which are prosthetic devices, not therapeutic devices.
No.
The device is a restorative material (yttria-stabilized zirconia) used for manufacturing dental prosthetics, not for diagnosing medical conditions.
No
The device description clearly states the devices are composed of yttria-stabilized zirconia, which is a physical material used for dental restorations. The summary focuses on the material properties and non-clinical testing of the physical 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 clearly states that the products are for the manufacturing of dental restorations (crowns, bridges, inlays, onlays, veneers, etc.). This is a manufacturing process for a medical device that will be implanted or placed in the body, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device is described as yttria-stabilized zirconia blocks used for milling. This is a material used to create a physical structure, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The focus is entirely on the physical properties and biocompatibility of the material for dental restorations.
- Classification: The classification according to ISO 6872 relates to dental materials, not IVD devices.
In summary, the device is a material used in the manufacturing of dental prosthetics, which are medical devices, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prettau®, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Prettau® 3, Prettau® 3 Coloured, Prettau® 3 Dispersive, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettau® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products have been developed for use with Colour Liquid, ICE Zirkon Ceramics, ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
Product codes
EIH
Device Description
The subject devices are composed of yttria-stabilized zirconia. They are available in different models that differ in form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.
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
Professional dental technicians
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
Non clinical testing was performed to determine the physical properties of the subject devices. In consideration of the International Standard ISO 6872 'Dentistry - Polymer-based crown and bridge materials', the devices were tested. All samples fulfil the requirements of the standard.
In consideration of the International Standards 10993-1 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing, the subject devices were tested. Biocompatibility testing demonstrated that no issue of biocompatibility arises.
The results of nonclinical tests demonstrate that the devices are equivalent to the predicate devices.
Key Metrics
Flexural Strength:
Prettau® 3, Prettau® 4 Anterior: 600 MPa
Prettau®, Prettau® 2, ICE group, Z-White : >= 900 MPa
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2019
Zirkonzahn srl. Sandra Leitner Regulatory Affairs Responsible Via An der Ahr 7 Gais BZ 39030 ITALY
Re: K183304
Trade/Device Name: PRETTAU®, ICE and Z-WHITE zirconia blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 11, 2019 Received: January 15, 2019
Dear Sandra Leitner:
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.
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
1
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,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 12:39:07 -04:04
12:39:07 -04'00'
Enclosure
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K183304
Device Name
PRETTAU®, ICE and Z-WHITE zirconia blanks
Indications for Use (Describe)
Prettau®, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Prettau® 3, Prettau® 3 Coloured, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettaw® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products have been developed for use with Colour Liquid, ICE Zirkon Stains and ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 05 510(k) Summary
510 (k) SUMMARY
510(K) NOTIFICATION
APPLICANT
ZIRKONZAHN SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 660 Fax: +39 0474 066 661 E-mail: info@zirkonzahn.com
CONTACT PERSON
Sandra Leitner Regulatory Affairs ZIRKONZAHN SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: +39 0474 066 784 Fax: +39 0474 066 661 E-mail: sandra.leitner@zirkonzahn.com
Date Summary Prepared: November 23, 2018
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | PRETTAU®, ICE and Z-WHITE zirconia blanks |
|---|---|
| Generic / Common Name: | Dental zirconia blanks |
| Regulation Number: | 872.6660 |
| Classification Name: | Porcelain powder for clinical use |
| Class: | II |
| Product Code: | EIH |
| Panel: | Dental |
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LEGALLY MARKETED PREDICATE DEVICE
| Company: | VITA Zahnfabrik H. Rauter GmbH Co. |
|---|---|
| Device Name: | VITA YZ ST and VITA YZ XT |
| Product Code: | EIH |
| 510(k) Number: | K180703 |
INDICATIONS FOR USE
Prettau®, Prettau® 2, Prettau® 2 Coloured, Prettau® 2 Dispersive, ICE Translucent, ICE Premium, ICE Abutment, ICE Translucent Plus, ICE Translucent Plus Coloured, ICE Translucent Plus Dispersive and Z-White are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.
Prettau® 3, Prettau® 3 Coloured, Prettau® 3 Dispersive, Prettau® 4 Anterior®, Prettau® 4 Anterior® Coloured and Prettau® 4 Anterior® Dispersive are destined for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872.
The products have been developed for use with Colour Liquid, ICE Zirkon Ceramics, ICE Zirkon Stains and ICE Zirkon Stains 3D. Observe the relative instructions of use when using these products. The blocks are suitable for all milling units, which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.
DEVICE DESCRIPTION
The subject devices are composed of yttria-stabilized zirconia. They are available in different models that differ in form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.
5
DISCUSSION OF NON CLINICAL TESTS
Non clinical testing was performed to determine the physical properties of the subject devices. In consideration of the International Standard ISO 6872 'Dentistry - Polymer-based crown and bridge materials', the devices were tested. All samples fulfil the requirements of the standard.
In consideration of the International Standards 10993-1 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing, the subject devices were tested. Biocompatibility testing demonstrated that no issue of biocompatibility arises.
The results of nonclinical tests demonstrate that the devices are equivalent to the predicate devices.
SUBSTANTIAL EQUIVALENCE DISCUSSION
The table below provides a more detailed comparison of the submitted devices and the predicate devices.
Both the Zirkonzahn devices and the predicates are made of yttria-stabilized zirconia that have a well- documented history for use in medical device applications and have been in use for many years.
The submitted devices and the predicates have similar indications for use as well as comparable technical, physical, chemical and biological properties and characteristics.
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| | PRETTAU®, ICE and Z-WHITE zirconia blanks | Predicate Device:
VITA YZ ST and VITA YZ XT
K180703 | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | ZIRKONZAHN SRL | VITA Zahnfabrik H. Rauter GmbH
Co. | |
| Regulation number | 872.6660 | 872.6660 | Same |
| Product Code | EIH | EIH | Same |
| Classification name | Porcelain Powder For Clinical Use | Porcelain Powder For Clinical Use | Same |
| ISO 6872 Class | Class 4
Prettau® 3, Prettau® 4 Anterior
Class 5
Prettau®, Prettau® 2, ICE group, Z-White | Class 4
VITA YZ XT
Class 5
VITA YZ ST | Same. The indications for use of the new devices as well as of the predicate devices were defined according to the recommended clinical indications in standard ISO 6872:2015. Thus, the indications for use of both are similar. |
| Composition | Based on yttria-stabilized zirconia | Based on yttria-stabilized zirconia | Similar |
| Models | Different shades and colors | Different shades and colors | Similar |
| Intended user | Professional dental technicians | Professional dental technicians | Same |
| Physical Properties | According to ISO 6872:2015 | According to ISO 6872:2015 | Same |
| Flexural Strength | Prettau® 3, Prettau® 4 Anterior: 600 MPa
Prettau®, Prettau® 2, ICE group, Z-White :
$\ge 900$ MPa | VITA YZ XT 678 MPa
VITA YZ ST 934 MPa | Similar |
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CONCLUSION
Based on the available information, the new devices are similar in function, composition, production technology and intended use. Therefore, we conclude that the proposed devices are substantially equivalent to the predicates.