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.

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.

AI/ML Overview

This document describes the premarket notification for PRETTAU®, ICE, and Z-WHITE zirconia blanks. It is not an AI/ML device, therefore the typical acceptance criteria and study data for such devices will not be present.

Here's a breakdown of the relevant information from the document, focusing on the "acceptance criteria" through the lens of a non-AI/ML medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (zirconia blanks for dental restorations), "acceptance criteria" are typically defined by recognized international standards for material properties, rather than performance metrics like sensitivity or specificity.

Acceptance Criteria (Standard)	Reported Device Performance (PRETTAU®, ICE, and Z-WHITE)
ISO 6872:2015 "Dentistry - Ceramic materials" (General requirements for Class 4 & Class 5)	All samples fulfill the requirements of the standard for their respective classes.
ISO 10993-1 "Biological Evaluation of Medical Devices" Part 1: Evaluation and Testing (Biocompatibility)	Biocompatibility testing demonstrated no issue of biocompatibility arises.
Flexural Strength (for Class 4 materials: min 500 MPa)	Prettau® 3, Prettau® 4 Anterior: 600 MPa
Flexural Strength (for Class 5 materials: min 800 MPa)	Prettau®, Prettau® 2, ICE group, Z-White: ≥ 900 MPa

Study Proving Device Meets Acceptance Criteria:

The document states: "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." It also mentions biocompatibility testing according to ISO 10993-1.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of samples used for physical or biocompatibility testing. It generally refers to "all samples" fulfilling the requirements, which implies a sufficient number were tested to demonstrate compliance.
Data Provenance: The testing was "non clinical testing," implying laboratory-based studies conducted by the manufacturer (Zirkonzahn srl. or an accredited lab on their behalf). The country of origin of the data is not explicitly stated but would presumably be related to where Zirkonzahn srl. is based (Italy) or where their testing facilities are located. The data is retrospective in the sense that it was collected prior to this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of device. The "ground truth" for material properties is established by adherence to published industrial and international standards (like ISO 6872) and objective physical and chemical testing methodologies, not by expert consensus or interpretations of images/data.

4. Adjudication Method

This concept is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., by radiologists or pathologists) to resolve discrepancies. Material property testing relies on objective measurements and established protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable to this type of device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, typically for diagnostic or screening devices. This device is a material for dental restorations.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is not an algorithm or AI system. It is a physical material (zirconia blanks).

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on established international standards (ISO series) for material properties (e.g., flexural strength, chemical composition, biocompatibility). These standards provide quantifiable criteria that the device must meet through objective physical and chemical testing.

8. Sample Size for the Training Set

This is not applicable as the device does not involve an AI/ML algorithm that requires a training set. The device is a manufactured material.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above; there is no AI/ML training set.

Summary

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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 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

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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)

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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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

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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 XTK180703	Comparison
Company	ZIRKONZAHN SRL	VITA Zahnfabrik H. Rauter GmbHCo.
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 4Prettau® 3, Prettau® 4 AnteriorClass 5Prettau®, Prettau® 2, ICE group, Z-White	Class 4VITA YZ XTClass 5VITA 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 MPaPrettau®, Prettau® 2, ICE group, Z-White :$\ge 900$ MPa	VITA YZ XT 678 MPaVITA 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.

Regulation Number and Section

§ 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.