Zirkonzahn COLOUR LIQUID devices are used for coloring milled and finished presintered zirconia structures. Coloring is performed by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400 ℃.

The Zirkonzahn COLOUR LIQUIDS are available in different colors and in different bottle sizes (20 ml, 50 ml, 100 ml).

AI/ML Overview

This document is a 510(k) Pre-market Notification for a dental device (Color Liquid, Vita Liquid). It establishes substantial equivalence to a predicate device, meaning it does not require a complex efficacy study with acceptance criteria and a human-in-the-loop study as would be required for an AI/ML device or a novel high-risk device.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests demonstrating that the coloring liquid does not negatively impact the functionality or biocompatibility of the zirconia structures it's applied to, and that the product is stable over its stated shelf life.

Here's a breakdown of the available information in relation to your request, highlighting what is provided and what is not applicable to this type of submission:

1. A table of acceptance criteria and the reported device performance:

The document mentions non-clinical tests to evaluate physical properties, shelf life, and biocompatibility. However, it does not provide specific acceptance criteria or quantitative results in a table format. It generally states that "The results show that the devices are well suited for their intended use."

The relevant sections are:

Section 05, "DISCUSSION OF NON CLINICAL TESTS" (page 5):
- "Non-clinical testing was performed to evaluate the physical properties of colored zirconia compared to untreated zirconia, to demonstrate that the subject device does not negatively impact the functionality of the zirconia. The results show that the devices are well suited for their intended use."
- "Furthermore, to establish the shelf life and storage conditions of the subject devices, real time aging was performed (including evaluation of color, workability and appearance) according to Zirkonzahn internal test protocols."
- "Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the non-clinical tests (physical properties, aging, biocompatibility).
Data Provenance: The tests were performed by Zirkonzahn ("Zirkonzahn internal test protocols" and "Zirkonzahn performed biocompatibility testing"). The country of origin for the data is implicitly Italy, where Zirkonzahn srl is located. These are laboratory tests, not clinical data from patients (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this device. The "ground truth" for the non-clinical tests would be defined by standardized test methods or internal protocols (e.g., measuring physical properties according to a standard, chemical analysis for biocompatibility). There are no human "experts" establishing clinical ground truth for image interpretation or diagnosis, as this is not an AI/ML diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert reads of medical images, to resolve discrepancies and establish a consensus ground truth. This document describes laboratory testing for a dental material.

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:

Not applicable. This is not an AI/ML device or a device requiring a clinical effectiveness study with human readers. It's a coloring liquid for dental zirconia.

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

Not applicable. This is not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests would be based on:
- Physical Property Measurements: Objective measurements against predefined specifications or baseline (untreated zirconia).
- Real-time Aging: Evaluation of objective characteristics like color, workability, and appearance over time, compared to initial properties and established shelf-life criteria.
- Biocompatibility: Results against established criteria from ISO 10993-1:2010 (e.g., cytotoxicity, sensitization, irritation tests for representative and worst-case mixtures). This is typically based on laboratory assay results.

8. The sample size for the training set:

Not applicable. This document does not describe an AI/ML device that requires training data.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

In summary, this 510(k) submission for a dental coloring liquid focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing of material properties, shelf-life, and biocompatibility, rather than clinical efficacy studies or AI/ML performance evaluation. Therefore, many of the requested details related to clinical trials, AI/ML performance metrics, and expert-based ground truth are not relevant or provided in this type of regulatory document.

Summary

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November 22, 2019

Zirkonzahn srl Sandra Leitner Regulatory Affairs Via An der Ahr 7 Gais, 39030 ITALY

Re: K190518

Trade/Device Name: Color Liquid, Vita Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 21, 2019 Received: October 24, 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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190518

Device Name Zirkonzahn COLOUR LIQUID

Indications for Use (Describe)	Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.
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Type of Use (Select one or both, as applicable)
Registration Use (Part 21 CFR 201.2 Subpart D) Over-The-Counter Use (21 CFR 201.2 Subpart C)	Registration Use (Part 21 CFR 201.2 Subpart D)	Over-The-Counter Use (21 CFR 201.2 Subpart C)
Registration Use (Part 21 CFR 201.2 Subpart D)	Over-The-Counter Use (21 CFR 201.2 Subpart C)

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

K190518

510 (k) SUMMARY

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 22, 2019

DEVICE IDENTIFICATION

Trade/Proprietary Name:	Zirkonzahn COLOUR LIQUID
Generic / Common Name:	Liquid for Dental Zirconia Prosthesis
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:	The Argen Corporation
Device Name:	ArgenZ Liquid Shade, Argen Z Incisal Effect, ArgenZ ColorModifier, ArgenZ Pontic Reducer
Product Code:	EIH
510(k) Number:	K182833

INDICATIONS FOR USE

Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.

DEVICE DESCRIPTION

The Zirkonzahn COLOUR LIQUIDS are available in different colors and in different bottle sizes (20 ml, 50 ml, 100 ml).

VITA tooth shades	A1, A2, A3, A3,5, A4B1, B2, B3, B4C1, C2, C3, C4D2, D3, D41M1, 1M22L1.5, 2M23M2, 3M34M2
VITA Bleach shades	0M1, 0M2, 0M3
ZZ Intensive shades	Tissue A, Tissue B, Tissue COrange 1, Brown 2Incisal grey, Incisal violet, Incisal blueLuNeA-Cervical, B-Cervical, C-Cervical, D-Cervical
ZZ Special liquids	TranslucentOpaqueFluorescence

The following colors are included in this submission:

The devices are used in the dental field by specialized technicians only.

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DISCUSSION OF NON CLINICAL TESTS

Non-clinical testing was performed to evaluate the physical properties of colored zirconia compared to untreated zirconia, to demonstrate that the subject device does not negatively impact the functionality of the zirconia. The results show that the devices are well suited for their intended use.

Furthermore, to establish the shelf life and storage conditions of the subject devices, real time aging was performed (including evaluation of color, workability and appearance) according to Zirkonzahn internal test protocols.

Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing. Zirkonzahn performed biocompatibility testing for representative mixtures and Worst Case mixtures of the subject devices or established biocompatibility through evaluation of the respective substances. Therefore Zirkonzahn divided the Colour Liquid devices into 6 different groups:

Colour Liquid groups	Biocompatibility
Main group	Tested on representative mixtures:- "lamelle COLOUR LIQUID"- "Campioni realizzati in polvere di zirconia(Prettau Zirkon) infiltrate con un liquido”Tested on Worst Cases:- Worst Case 1- Worst Case 2- Worst Case 3
Colour Liquid Aquarell Bio-Pigment	Evaluated
Colour Liquid PrettauAquarell - Translucent	Evaluated
Colour Liquid PrettauAquarell - Opaque	Evaluated
Thinner	Evaluated
Stabilizer	Evaluated

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SUBSTANTIAL EQUIVALENCE

	ZirkonzahnCOLOUR LIQUID(new devices)	ArgenZ Liquids(K182833)	Comparison
Company	Zirkonzahn srl	The Argen Corporation
Product Code	EIH	EIH	Same
RegulationNumber	872.6660	872.6660	Same
RegulationName	Porcelain powder forclinical use	Porcelain powder forclinical use	Same
Indications foruse	ZirkonzahnCOLOURLIQUID is used forcoloring pre-sinteredzirconia structures.	ArgenZ Liquids areintended to be usedby trained dentaltechnicians as anaccessory forshading ArgenZframeworks andArgenZ allzirconia,monolithicrestorations foranterior andposterior dentalprosthetics.	Similar
ChemicalComposition	Aqueous solutions oftransition andlanthanoid metal salts	Aqueous solutions oftransition andlanthanoid metalsalts	Similar
Biocompatibility	Established	Established	Same
Principles ofOperation	Brushing orDippingTechnique	Brushing or DippingTechnique	Same
Type ofPackaging andVolume	Bottle; 20 ml,50 ml,100 ml	Bottle; 30 ml, 100 ml	Similar
Shade	Various, including A1-D4	Various, includingA1-D4	Similar
StorageConditions	Max. 25 °C5 years	25 - 75 °C2 years	Minordifference

The table above provides a detailed comparison of the submitted devices and the predicate devices. Both devices are liquids used for coloring pre-sintered zirconia structures. They only slightly differ in their storage conditions. However, Zirkonzahn evaluated the storage conditions for the Zirkonzahn COLOUR LIQUID devices with real life functional testing and concluded that these indications are appropriate. Therefore, Zirkonzahn concludes that this difference can be rated as minor.

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CONCLUSION

Based on the available information, the new devices and the predicates are similar in function, production technology and intended use. Therefore, we conclude that the proposed devices are substantially equivalent to the predicate.

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.