K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent

K173971 · Yeti Dentalprodukte GmbH · EIH · Nov 15, 2018 · Dental

Device Facts

• Record ID: K173971
• Device Name: K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent
• Applicant: Yeti Dentalprodukte GmbH
• Product Code: EIH · Dental
• Decision Date: Nov 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Zircon Blanks are used for milling using digital stl-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations. All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the general public or over-the-counter.

Device Story

Yeti K2 Zircon Blanks are ceramic discs composed of zirconium oxide (ZrO2 + HfO2 + Y2O3, Al2O3, and other oxides). Used in dental clinics/laboratories by dental professionals; blanks are machined via CAD/CAM or copy milling systems using digital STL files to produce crowns, bridges, and monolithic dental restorations. Blanks may be colored using Dip & Brush K2 CAD CAM Zircon Liquids prior to sintering. Final restorations provide structural support for dental prosthetics. Benefits include patient-specific, durable, and aesthetic dental restorations.

Clinical Evidence

No clinical data. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, haemolysis, acute systemic toxicity, irritation, sensitization, pyrogenicity, chromosomal aberration, and long-term implantation. Bench testing conducted on raw material and product batches for chemical composition and physical properties.

Technological Characteristics

Ceramic discs (zirconium oxide). Composition: ZrO2 + HfO2 + Y2O3 (>99.5%), Al2O3, and other oxides. Dimensions: 95 or 98.5 mm diameter, 10-25 mm height. Sintering parameters: 1450°C for 2 hours or 1500°C for 1 hour. Single-use, non-sterile. Mechanical properties: bulk density, grain size, flexural bending strength, fracture toughness, Vickers hardness, thermal coefficient, radioactivity, and solubility.

Indications for Use

Indicated for dental patients requiring anterior or posterior restorations, including single crowns and bridges (up to 2 intermediate elements for white classic/translucent, 1 for extreme translucent). Not for general public or OTC use.

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

• Z-CAD HD (K072569)

Reference Devices

• Ceramill® zi (K063511)
• Zolid FX (K152383)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Yeti Dentalprodukte Gmbh Thomas Biskupski General Manager Industriestrasse 3a Engen, 78234 GERMANY November 15, 2018

Re: K173971

Trade/Device Name: K2 Zirkon Blank White Classic; K2 Zirkon Blank Translucent; K2 Blank Extreme Translucent Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 20, 2018 Received: August 23, 2018

Dear Thomas Biskupski:

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

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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 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.htm); 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 mediation-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.

Digitally signed by Mary S. Runner -S3 Mary S. Runner -S3 13:23:04 -05'00'

forTina 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) K173971

Device Name

K2 Zircon Blank white classic, K2 Zircon Blank translucent, K2 Zircon Blank extreme translucent

#### Indications for Use (Describe)

Zircon Blanks are used for milling using digital stl-files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations.

Table 1: Indication of use and maximum intermediate elements.

| | Single crown | | Bridges | |
|----------------------------------------|--------------|-----------|----------|-----------|
| | Anterior | Posterior | Anterior | Posterior |
| K2 Zircon Blank<br>white classic | X | X | 2 | 2 |
| K2 Zircon Blank<br>translucent | X | X | 2 | 2 |
| K2 Zircon Blank<br>extreme translucent | X | X | 1 | - |

All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the general public or over-the-counter.

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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Image /page/3/Picture/0 description: The image shows the logo for Yeti Dental. The logo features a mountain range above the word "YETI" in a bold, shadowed font. Below "YETI" is the word "DENTAL" in a smaller, bold font.

# 510(k) Summary K173971

| Submitter | Yeti Dentalprodukte GmbH<br>Industriestrasse 3<br>78234 Engen - Germany |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Thomas Biskupski |
| Date Prepared | August 15th, 2018 |
| K Number | K173971 |
| Device | |
| Name of Device | K2 CAD CAM Zircon Blank white classic,<br>K2 CAD CAM Zircon Blank translucent,<br>K2 CAD CAM Zircon Blank extreme translucent |
| Common Name | Powder, Porcelain |
| Classification Name | Porcelain powder for clinical use |
| Regulatory Class | II |
| Product Code | EIH |
| Predicate Device | |
| K2 Zirconia Blank white classic: | Z-CAD HD (K072569) |
| Reference Devices | |
| K2 Zirconia Blank translucent: | Ceramill® zi (K063511) |
| K2 Zirconia Blank extreme translucent: | Zolid FX (K152383) |

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Image /page/4/Picture/0 description: The image shows a logo for "YETI DENTAL". The logo features a stylized mountain range above a blue banner. The word "YETI" is written in large, bold, black letters on the blue banner, and the word "DENTAL" is written in smaller, bold, black letters below the banner.

### Device Description

The Yeti K2 Zircon Blanks are ceramic blanks, which are indicated for the production of dentalprosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology and for milling using digital STL files to produce Crowns, Bridges and monolithic works made from zirconium oxide.

The Yeti Dip & Brush K2 liquids are ready for use water-based products. These liquids are specifically formulated for the colorization of K2 Zircon Blanks from Yeti Dentalprodukte GmbH.

## Indications for Use

Zircon Blanks are used for milling using digital STL files to produce Crowns, Bridges and monolithic works. We propose the K2 Zircon Blanks for anterior and posterior restorations.

| | Single crown | | Bridges | |
|----------------------------------------|--------------|-----------|----------|-----------|
| | Anterior | Posterior | Anterior | Posterior |
| K2 Zircon Blank<br>white classic | x | x | 2 | 2 |
| K2 Zircon Blank<br>translucent | x | x | 2 | 2 |
| K2 Zircon Blank<br>extreme translucent | x | x | 1 | - |

Table 1: Indication of use and maximum intermediate elements

All K2 Zircon Blanks are indicated to be colored with Dip & Brush K2 CAD CAM Zircon Liquids. K2 Zircon Blanks should be not used by the General public or over-the-counter.

### Comparison of Technological Characteristics with the predicate device

All compared characteristics: Chemical Composition and specifications are the same for the subject and the predicate devices. There are no significant deviations.

The material consists of ZrO2 + HfO2 + Y2O3, Y2O3, Al2O3 and other Oxides in the subject and the predicate devices.

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Image /page/5/Picture/0 description: The image is a logo for Yeti Dental. The logo features a mountain range above the word "YETI" in a bold, sans-serif font, with a blue background behind the word. Below "YETI" is the word "DENTAL" in a smaller, sans-serif font.

The shapes and dimensions are also comparable for the K2 Zircon Blank white classic, translucent and extreme translucent, with they're predicate devices.

The defined specifications for the K2 Zircon Blank white classic, translucent and extreme translucent: Bulk density, Grain Size, Flexural Bending Strength, Fracture Toughness, Hardness (Vicker's Hardness), Coefficient of Thermal, Radioactivity (raw material) and Solubility (acetic acid) have no significant deviations to the predicate devices.

Except for the K2 Zircon Blank white classic, there was no comparable value found for the specifications translucency and Thermal conductivity.

### Performance Data

### Biocompatibility testing:

The biocompatibility evaluation for the K2 Zircon Blanks was conducted to several standards for cytotoxicity, haemolysis, acute systematic toxicity, irritation, sensitization, pyrogen, chromosomal abbreviation and long-term implantation. All tests were performed in accordance to ISO 10993-1.

### Bench test for each raw material or product batch:

The chemical composition and several properties are tested for each raw material batch or product batch.

### Shelf Life:

Shelf-life for the K2 Zircon Blanks was set at 10 years by Yeti.

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Image /page/6/Picture/0 description: The image shows a logo for Yeti Dental. The logo features a mountain range above the word "YETI" in bold, shadowed letters. Below "YETI" is the word "DENTAL" in a smaller, bold font.

Technological Characteristics:

| | New Device | Predicate Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | K2 Zircon Blank white classic | Z-CAD HD |
| 510(k) number | K173971 | K072569 |
| 510(k)<br>submitter/ holder | YETI DENTALPRODUKTE | METOXIT |
| Product Code | EIH | EIH |
| Applications | CAD / CAM fabrication | CAD / CAM<br>Fabrication |
| Material<br>ZrO2 + HfO2 + Y2O3 | > 99.5 % | > 99.5 % |
| Shape | Disks | Disks |
| Dimensions | Various<br>(Diameter: 95 or 98.5 mm<br>Height: 10 to 25 mm) | Various<br>(Diameter: 95 or 98.5 mm<br>Height: 10 to 25 mm) |
| Sterility | No | No |
| Single Use | Yes | Yes |
| Sintering Parameters | 1450°C - 2 hours<br>1500°C - 1 hour | 1450°C - 2 hours<br>1500°C - 1 hour |
| Indications for use | Zircon Blanks are used for milling<br>using digital STL-files to produce<br>Crowns, Bridges and monolithic<br>works. We propose the K2 Zircon<br>Blanks for anterior and posterior<br>restorations. | Metoxit blanks are indicated for<br>use as a substructure for<br>porcelain fused ceramic fixed<br>dental restorations. |

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Image /page/7/Picture/0 description: The image shows the logo for Yeti Dental. The logo features a mountain range above the word "YETI" in a bold, shadowed font, set against a blue background. Below "YETI" is the word "DENTAL" in a smaller, sans-serif font.

## Conclusions

Based on all information shown above and all performed testing the K2 Zircon Blank white classic, K2 Zircon Blank translucent and K2 Zircon Blank extreme translucent from Yeti Dentalprodukte GmbH are substantially equivalent to the predicate and reference devices.