VITA YZ ST and VITA YZ XT

K180703 · Vita Zahnfabrik H.Rauter GmbH Co. · EIH · Aug 1, 2018 · Dental

Device Facts

• Record ID: K180703
• Device Name: VITA YZ ST and VITA YZ XT
• Applicant: Vita Zahnfabrik H.Rauter GmbH Co.
• Product Code: EIH · Dental
• Decision Date: Aug 1, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

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.

Device Story

VITA YZ ST and VITA YZ XT are pre-sintered yttrium-stabilized zirconia (Y-TZP) blanks; used as raw material for dental CAD/CAM milling systems. Dental technicians or clinicians mill blanks into anatomical crowns, bridges, or frameworks; restorations are subsequently sintered to achieve final physical properties. Devices provide high-translucency zirconia to match natural dentition. Output is a custom-milled dental restoration; used to restore tooth function and aesthetics. No software or algorithm is integral to the material itself; processing relies on external CAD/CAM hardware/software.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including ISO 6872:2015 (Dentistry, Ceramic materials), EN ISO 9693-2:2016 (Compatibility Testing), and biocompatibility testing per ISO 10993-1:2009 and ISO 7405:2008.

Technological Characteristics

Pre-sintered yttrium-stabilized tetragonal zirconia polycrystal (Y-TZP) blanks. Available in disc and block configurations. Compliant with ISO 6872:2015 and EN ISO 9693-2:2016. Flexural strength: VITA YZ ST (934 ± 104 MPa), VITA YZ XT (678 ± 62 MPa).

Indications for Use

Indicated for patients requiring dental restorations including fully anatomical anterior/posterior crowns, multi-unit bridges, and frameworks. VITA YZ ST is indicated for anterior/posterior crowns, multi-unit bridges, screw-retained restorations, and frameworks. VITA YZ XT is indicated for anterior/posterior crowns, 3-unit bridges, and frameworks.

Regulatory Classification

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.

Predicate Devices

• VITA In–CERAM YZ Cubes for CEREC® (K022996)

Reference Devices

• priti® multidisc Zr02 High Translucent (K161025)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

K180703

| Submitter | VITA Zahnfabrik H.Rauter GmbH Co.<br>Spitelgasse 3<br>Bad Sackingen, D-79713<br>Germany<br>Establishment Reg. No. 1000625496 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bernd Walker<br>Head of Regulatory Affairs and Quality Systems<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Official Correspondent | Nevine Erian<br>Director, Regulatory Affairs & Compliance (Consultant)<br>VITA North America, Inc.<br>22705 Savi Ranch Parkway, Suite 100<br>Yorba Linda, CA 92887<br>Establishment Reg. No. 2082832<br>Phone [phone]<br>Fax [phone]<br>E-mail: [e-mail] |
| 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

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.

#### 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-<br>CERAM YZ<br>(Primary<br>Predicate) | priti® multidisc<br>Zr02 HT<br>(Reference<br>Predicate) |
|--------------------------------------------------------------------------------------------|----------------------|------------------------------------------------|---------------------------------------------------------|
| Indications | | | |
| Fully anatomical anterior and<br>posterior crowns | ST – Yes<br>XT – Yes | Yes | Yes |
| Multi-unit fully anatomical<br>anterior and posterior bridges | ST – Yes<br>XT – Yes | Yes | Yes |
| Fully anatomical crowns and<br>multi-unit bridges on direct<br>screw-retained restorations | ST – Yes<br>XT – No | Yes | Yes |

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| Technical Attribute | VITA YZ ST and XT | VITA IN-<br>CERAM YZ<br>(Primary<br>Predicate) | priti® multidisc<br>Zr02 HT<br>(Reference<br>Predicate) |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------|---------------------------------------------------------|
| Single-tooth and multi-unit<br>bridge frameworks of anterior<br>and posterior crowns and<br>bridges. | ST - Yes<br>XT - Yes | Yes | Yes |
| Fully anatomical 3-unit<br>anterior and posterior bridges | ST - Yes<br>XT - Yes | Yes | Yes |
| Anterior and posterior single-<br>tooth and 3-unit bridge<br>frameworks | ST - Yes<br>XT - Yes | Yes | Yes |
| CAD/CAM Material | Yes | Yes | Yes |
| Physical Configuration | Disc Form | Disc & Block<br>Form | Disc & Block Form |
| Shades | Different shades | Different<br>shades | Different shades |
| Meets ISO 6872 Req'ts | Yes | Yes | Yes |
| Flexural Strength | VITA YZ ST 934 ± 104 MPa<br>VITA 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.