VITA YZ® ST is indicated for fully anatomical anterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.

VITA YZ® XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.

Device Description

VITA YZ ST and VITA YZ XT discs are pre-sintered zirconia materials, partially stabilized with yttrium oxide (Y-TZP, yttria stabilized tetragonal zirconia polycrystal). VITA YZ ST is made of Super Translucent Zirconia and VITA YZ XT is made of Extra Translucent Zirconia. They offer higher translucency to better match natural dentition.

AI/ML Overview

This document describes the premarket notification (510(k)) for two dental materials, VITA YZ ST and VITA YZ XT (zirconia blanks for fabricating dental restorations).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative sense for all attributes. Instead, it refers to meeting specific international standards and demonstrating "similar" properties to predicate devices. For mechanical strength, a direct comparison is given.

Acceptance Criteria / Standard Met	Reported VITA YZ ST Performance	Reported VITA YZ XT Performance	Predicate (VITA IN-CERAM YZ) Performance	Predicate (priti® multidisc Zr02 HT) Performance
Material Composition (similar to predicate)	Yes	Yes	Identical Yttrium-Stabilized Zirconia	Similar Zirconia
Physical Properties (similar to predicate)	Yes	Yes	Yes	Yes
Indications for Use (similar to predicate)	Yes	Yes	Yes	Yes
Meet ISO 6872:2015 – Dentistry, Ceramic materials (requirements)	Yes	Yes	Yes	Yes
Meet EN ISO 9693-2:2016 – Dentistry, Compatibility Testing, Ceramic-ceramic systems (requirements)	Yes	Yes	Not explicitly stated for predicate	Not explicitly stated for predicate
Meet Biocompatibility requirements per ISO 10933-1:2009	Yes	Yes	Yes	Yes
Meet Biocompatibility requirements per ISO 7405:2008	Yes	Yes	Yes	Yes
Flexural Strength (MPa)	934 ± 104 MPa	678 ± 62 MPa	1165 ± 56 MPa	> 650 MPa

Note: For many criteria, the "performance" is stated as meeting a standard or being "similar" rather than a specific numerical result. The flexural strength is the most quantitative comparison provided. The conclusion explicitly states that "The differences between VITA YZ ST & VITA YZ XT and the predicate devices do not impact safety and effectiveness, as VITA YZ ST & VITA YZ XT share same indications as the predicate devices, meet the same biocompatibility, and ISO 6872 test criteria."

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

The document does not specify a "test set" in the context of clinical data or human-derived data. All performance testing described is non-clinical (bench testing) and biocompatibility testing.

Sample Size for Bench Tests: Not explicitly stated for flexural strength or other mechanical/physical properties. Standard testing methods (e.g., ISO 6872) typically define minimum sample sizes for such tests.
Data Provenance: The data is generated from non-clinical bench testing. The country of origin for the testing is not specified, but the applicant (VITA Zahnfabrik H.Rauter GmbH Co.) is located in Germany.
Retrospective or Prospective: Not applicable as no clinical data or human studies were conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in the context of clinical diagnosis or interpretation by experts is not relevant here, as this is a materials science evaluation and not a diagnostic device. The "truth" is established by conformance to international material standards and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication involving human readers/interpreters was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a dental material, not a diagnostic or AI-assisted diagnostic device. The study focused on material properties and biocompatibility.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a material for fabricating dental restorations, not an algorithm.

7. The Type of Ground Truth Used

For material properties (e.g., flexural strength, compliance with ISO 6872): The "ground truth" is defined by the requirements of the international standards (e.g., ISO 6872) and measurable physical properties determined through laboratory testing using standardized methodologies.
For biocompatibility: The "ground truth" is established by conformance to the requirements of the international standards for biocompatibility (ISO 10993-1 and ISO 7405) through specific biological evaluation tests.

8. The Sample Size for the Training Set

Not applicable. No "training set" in the context of machine learning or AI development was used, as this is a material science product.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in a smaller font, also in blue.

August 1, 2018

VITA Zahnfabrik H.Rauter GmbH Co. % Nevine Erian Director, Regulatory Affairs & Compliance (Consultant) VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda, California 92887

Re: K180703

Trade/Device Name: VITA YZ ST and VITA YZ XT Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 30, 2018 Received: May 31, 2018

Dear Nevine Erian:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K180703

Device Name

VITA YZ® ST and VITA YZ® XT

Indications for Use (Describe)

VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.

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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510(k) Summary

K180703

Submitter	VITA Zahnfabrik H.Rauter GmbH Co.Spitelgasse 3Bad Sackingen, D-79713GermanyEstablishment Reg. No. 1000625496
Contact	Bernd WalkerHead of Regulatory Affairs and Quality SystemsPhone (+49) 7761 562-361Fax (+49) 7761 562-384B.Walker@vita-zahnfabrik.com
Official Correspondent	Nevine ErianDirector, Regulatory Affairs & Compliance (Consultant)VITA North America, Inc.22705 Savi Ranch Parkway, Suite 100Yorba Linda, CA 92887Establishment Reg. No. 2082832Phone (949) 370-7155Fax (714) 221-6759E-mail: nerian@vitanorthamerica.com
Date Prepared	May 29, 2018

Trade/Device Name VITA YZ® ST and VITA YZ® XT 트
Common Name Zirconia Based , CAD/CAM Material ■
트 Classification Name Porcelain powder for clinical use
. Regulation Number 21 CFR 872.6660
. Product Code EIH

Predicate Devices

VITA In–CERAM YZ Cubes for CEREC® (VITA Zahnfabrik GmbH) – K022996 – Primary Predicate

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priti® multidisc Zr02 High Translucent ( pritidenta GmbH) – K161025 – Reference Predicate

Device Description

Statement of Intended Use

VITA YZ® ST and VITA YZ® XT materials are blanks used for fabricating dental restorations.

VITA YZ ST is indicated for fully anatomical anterior and posterior crowns, multi-unit fully anatomical anterior and posterior bridges, fully anatomical crowns and multi-unit bridges on direct screw-retained restorations, and single-tooth and multi-unit bridge frameworks of anterior and posterior crowns and bridges.

VITA YZ XT is indicated for fully anatomical anterior and posterior crowns, fully anatomical 3-unit anterior and posterior bridges, and anterior and posterior single-tooth and 3-unit bridge frameworks.

Material Composition

VITA YZ ST and YZ XT are formulated with yttrium-stabilized zirconia which is identical to the predicate device VITA YZ T (KO22996). VITA YZ ST and VITA YZ XT have higher amounts of yttrium, for increased translucency, compared to VITA YZ T.

Technological Characteristics

VITA YZ products are offered in disc and block configurations, in different shades. Blocks have a mandrel attachment, to permit securing into a CAD/CAM machine for milling into a restoration.

Non-Clinical Performance Testing

VITA YZ ST and VITA YZ XT were tested and met the requirements of the following standards:

. ISO 6872:2015 – Dentistry, Ceramic materials
EN ISO 9693-2:2016 - Dentistry, Compatibility Testing, Ceramic-ceramic systems

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Bench test results allowed us to conclude that VITA YZ ST and VITA YZ XT meet their intended use.

Biocompatibility

VITA YZ ST and VITA YZ XT meet biocompatibility requirements of the following standards:

i ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
. ISO 7405:2008 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Clinical Performance Data

Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA YZ ST and VITA YZ XT.

Substantial Equivalence

Material

VITA YZ ST and YZ XT are similar in chemical composition as the predicate devices.

Physical Properties

VITA YZ ST and YZ XT have similar physical properties as the predicate devices.

Technical Comparison of VITA YZ ST and YZ XT to Predicate Devices

Technical Attribute	VITA YZ ST and XT	VITA IN-CERAM YZ(PrimaryPredicate)	priti® multidiscZr02 HT(ReferencePredicate)
Indications
Fully anatomical anterior andposterior crowns	ST – YesXT – Yes	Yes	Yes
Multi-unit fully anatomicalanterior and posterior bridges	ST – YesXT – Yes	Yes	Yes
Fully anatomical crowns andmulti-unit bridges on directscrew-retained restorations	ST – YesXT – No	Yes	Yes

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Technical Attribute	VITA YZ ST and XT	VITA IN-CERAM YZ(PrimaryPredicate)	priti® multidiscZr02 HT(ReferencePredicate)
Single-tooth and multi-unitbridge frameworks of anteriorand posterior crowns andbridges.	ST - YesXT - Yes	Yes	Yes
Fully anatomical 3-unitanterior and posterior bridges	ST - YesXT - Yes	Yes	Yes
Anterior and posterior single-tooth and 3-unit bridgeframeworks	ST - YesXT - Yes	Yes	Yes
CAD/CAM Material	Yes	Yes	Yes
Physical Configuration	Disc Form	Disc & BlockForm	Disc & Block Form
Shades	Different shades	Differentshades	Different shades
Meets ISO 6872 Req'ts	Yes	Yes	Yes
Flexural Strength	VITA YZ ST 934 ± 104 MPaVITA YZ XT 678 ± 62 MPa	1165 ± 56 MPa	> 650 MPa

Conclusion

Information provided in this application demonstrates that VITA YZ ST and VITA YZ XT are substantially equivalent in safety and effectiveness to the predicate devices. VITA YZ ST & VITA YZ XT have similar indications for use, similar material composition, similar physical properties, and similar technological characteristics as VITA In-CERAM YZ Cubes for CEREC® and priti® multidisc Zr02 HT. The differences between VITA YZ ST & VITA YZ XT and the predicate devices do not impact safety and effectiveness, as VITA YZ ST & VITA YZ XT share same indications as the predicate devices, meet the same biocompatibility, and ISO 6872 test criteria.

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.