(321 days)
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 Blankwhite classic | X | X | 2 | 2 |
| K2 Zircon Blanktranslucent | X | X | 2 | 2 |
| K2 Zircon Blankextreme 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.
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.
This document is a 510(k) premarket notification for a dental device, specifically Zirconium Oxide blanks used for milling dental restorations. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not applicable to this type of submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in the form of performance thresholds (e.g., in terms of accuracy, sensitivity, or specificity) for the device itself in a study format. Instead, it demonstrates substantial equivalence to predicate devices based on:
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (K2 Zircon Blanks) |
|---|---|---|
| Chemical Composition | Comparable to predicate device (> 99.5% ZrO2 + HfO2 + Y2O3) | > 99.5% ZrO2 + HfO2 + Y2O3 |
| Shapes and Dimensions | Comparable to predicate devices | Disks (Diameter: 95 or 98.5 mm, Height: 10 to 25 mm) |
| Bulk Density | No significant deviations to predicate devices | Tested for each batch |
| Grain Size | No significant deviations to predicate devices | Tested for each batch |
| Flexural Bending Strength | No significant deviations to predicate devices | Tested for each batch |
| Fracture Toughness | No significant deviations to predicate devices | Tested for each batch |
| Hardness (Vicker's) | No significant deviations to predicate devices | Tested for each batch |
| Coefficient of Thermal | No significant deviations to predicate devices | Tested for each batch |
| Radioactivity (raw material) | No significant deviations to predicate devices | Tested for each batch |
| Solubility (acetic acid) | No significant deviations to predicate devices | Tested for each batch |
| Biocompatibility | Compliance with ISO 10993-1 standards | Tested for cytotoxicity, haemolysis, acute systematic toxicity, irritation, sensitization, pyrogen, chromosomal abbreviation and long-term implantation; all performed in accordance with ISO 10993-1. |
| Shelf Life | Established shelf-life | 10 years |
| Sintering Parameters | Identical to predicate device | 1450°C - 2 hours, 1500°C - 1 hour |
Note: The document explicitly states: "Except for the K2 Zircon Blank white classic, there was no comparable value found for the specifications translucency and Thermal conductivity" for the predicate device. This indicates that for these specific properties, direct comparison was not possible, but it doesn't indicate a failure to meet acceptance criteria, as the overall substantial equivalence argument is based on the totality of characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a dental material (zirconium oxide blanks), not an AI/software device. Therefore, there is no "test set" in the context of an AI study for diagnostic performance. The "tests" mentioned are material property tests and biocompatibility tests.
- Sample Size: Not specified in terms of a "test set" as understood in AI studies. The performance data refers to "bench test for each raw material or product batch" and "biocompatibility evaluation." The number of samples for these tests is not quantified in the provided text, but it implies ongoing quality control and a specific evaluation for biocompatibility.
- Data Provenance: Not applicable in the context of clinical data for AI; the data refers to material testing conducted by the manufacturer, Yeti Dentalprodukte GmbH, in Germany. The biocompatibility tests were conducted according to ISO 10993-1.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The device is a dental material, not a diagnostic device requiring expert interpretation or ground truth establishment in the diagnostic sense. The "ground truth" for material properties is established through standardized physical and chemical tests (e.g., ISO standards, lab measurements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There is no "test set" for diagnostic performance and no human interpretation requiring adjudication in this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. An MRMC study is relevant for comparing human reader performance with and without AI assistance for diagnostic tasks. This device is a dental material, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device relates to its physical, chemical, and biological properties. This is established through:
- Standardized material testing: Measurements of properties like chemical composition, bulk density, grain size, flexural bending strength, fracture toughness, hardness, coefficient of thermal expansion, radioactivity, and solubility. These are objective laboratory measurements, not subjective expert consensus.
- Biocompatibility testing against ISO standards: Compliance with ISO 10993-1, which involves specific tests for cytotoxicity, haemolysis, etc.
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a material rather than an AI or machine learning algorithm.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Blankwhite classic | X | X | 2 | 2 |
| K2 Zircon Blanktranslucent | X | X | 2 | 2 |
| K2 Zircon Blankextreme 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 GmbHIndustriestrasse 378234 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,K2 CAD CAM Zircon Blank translucent,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 Blankwhite classic | x | x | 2 | 2 |
| K2 Zircon Blanktranslucent | x | x | 2 | 2 |
| K2 Zircon Blankextreme 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)submitter/ holder | YETI DENTALPRODUKTE | METOXIT |
| Product Code | EIH | EIH |
| Applications | CAD / CAM fabrication | CAD / CAMFabrication |
| MaterialZrO2 + HfO2 + Y2O3 | > 99.5 % | > 99.5 % |
| Shape | Disks | Disks |
| Dimensions | Various(Diameter: 95 or 98.5 mmHeight: 10 to 25 mm) | Various(Diameter: 95 or 98.5 mmHeight: 10 to 25 mm) |
| Sterility | No | No |
| Single Use | Yes | Yes |
| Sintering Parameters | 1450°C - 2 hours1500°C - 1 hour | 1450°C - 2 hours1500°C - 1 hour |
| Indications for use | Zircon Blanks are used for millingusing digital STL-files to produceCrowns, Bridges and monolithicworks. We propose the K2 ZirconBlanks for anterior and posteriorrestorations. | Metoxit blanks are indicated foruse as a substructure forporcelain fused ceramic fixeddental 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.
§ 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.