Color Liquid, Vita Liquid

K190518 · Zirkonzahn Srl · EIH · Nov 22, 2019 · Dental

Device Facts

• Record ID: K190518
• Device Name: Color Liquid, Vita Liquid
• Applicant: Zirkonzahn Srl
• Product Code: EIH · Dental
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

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

Device Story

Zirkonzahn COLOUR LIQUID consists of aqueous solutions of transition and lanthanoid metal salts used to color milled, pre-sintered zirconia dental structures. Used by specialized dental technicians in a laboratory setting; application via dipping or metal-free brush. After coloring, structures are dried and sintered at temperatures above 1400 °C. The device provides various VITA and intensive shades to achieve desired aesthetic outcomes for dental prosthetics. Benefits include improved aesthetic matching of zirconia restorations to natural dentition.

Clinical Evidence

Bench testing only. Testing evaluated physical properties of colored zirconia versus untreated zirconia to ensure no negative impact on functionality. Biocompatibility established per ISO 10993-1:2010 via testing of representative and worst-case mixtures. Shelf life and storage conditions validated through real-time aging protocols evaluating color, workability, and appearance.

Technological Characteristics

Aqueous solutions of transition and lanthanoid metal salts. Available in 20 ml, 50 ml, and 100 ml bottles. Application via manual dipping or brush. Sintering required at >1400 °C. Biocompatibility evaluated per ISO 10993-1:2010.

Indications for Use

Indicated for coloring pre-sintered zirconia structures in dental prosthetics by specialized dental technicians.

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

• ArgenZ Liquid Shade, Argen Z Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer (K182833)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".

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

{1}------------------------------------------------

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

{2}------------------------------------------------

## 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. |
|--------------------------------|---------------------------------------------------------------------------------|
|--------------------------------|---------------------------------------------------------------------------------|

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><div style="display:inline-block;"> <input checked="true" type="checkbox"/> </div> Registration Use (Part 21 CFR 201.2 Subpart D) </td><td><div style="display:inline-block;"> <input type="checkbox"/> </div> Over-The-Counter Use (21 CFR 201.2 Subpart C) </td></tr></table> | <div style="display:inline-block;"> <input checked="true" type="checkbox"/> </div> Registration Use (Part 21 CFR 201.2 Subpart D) | <div style="display:inline-block;"> <input type="checkbox"/> </div> Over-The-Counter Use (21 CFR 201.2 Subpart C) |
| <div style="display:inline-block;"> <input checked="true" type="checkbox"/> </div> Registration Use (Part 21 CFR 201.2 Subpart D) | <div style="display:inline-block;"> <input type="checkbox"/> </div> 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## Section 05 510(k) Summary

#### K190518

#### 510 (k) SUMMARY

### APPLICANT

ZIRKONZAHN SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### CONTACT PERSON

Sandra Leitner Regulatory Affairs ZIRKONZAHN SRL Via An der Ahr 7 Gais, ITALY 39030 Phone: [phone] Fax: [phone] E-mail: [e-mail]

### 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 |

{4}------------------------------------------------

### LEGALLY MARKETED PREDICATE DEVICE

| Company: | The Argen Corporation |
|----------------|----------------------------------------------------------------------------------------------|
| Device Name: | ArgenZ Liquid Shade, Argen Z Incisal Effect, ArgenZ Color<br>Modifier, 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

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).

| VITA tooth shades | A1, A2, A3, A3,5, A4<br>B1, B2, B3, B4<br>C1, C2, C3, C4<br>D2, D3, D4<br>1M1, 1M2<br>2L1.5, 2M2<br>3M2, 3M3<br>4M2 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| VITA Bleach shades | 0M1, 0M2, 0M3 |
| ZZ Intensive shades | Tissue A, Tissue B, Tissue C<br>Orange 1, Brown 2<br>Incisal grey, Incisal violet, Incisal blue<br>LuNe<br>A-Cervical, B-Cervical, C-Cervical, D-Cervical |
| ZZ Special liquids | Translucent<br>Opaque<br>Fluorescence |

The following colors are included in this submission:

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

{5}------------------------------------------------

## 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:<br>- "lamelle COLOUR LIQUID"<br>- "Campioni realizzati in polvere di zirconia<br>(Prettau Zirkon) infiltrate con un liquido”<br>Tested on Worst Cases:<br>- Worst Case 1<br>- Worst Case 2<br>- Worst Case 3 |
| Colour Liquid Aquarell Bio-<br>Pigment | Evaluated |
| Colour Liquid Prettau<br>Aquarell - Translucent | Evaluated |
| Colour Liquid Prettau<br>Aquarell - Opaque | Evaluated |
| Thinner | Evaluated |
| Stabilizer | Evaluated |

{6}------------------------------------------------

# SUBSTANTIAL EQUIVALENCE

| | Zirkonzahn<br>COLOUR LIQUID<br>(new devices) | ArgenZ Liquids<br>(K182833) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Zirkonzahn srl | The Argen Corporation | |
| Product Code | EIH | EIH | Same |
| Regulation<br>Number | 872.6660 | 872.6660 | Same |
| Regulation<br>Name | Porcelain powder for<br>clinical use | Porcelain powder for<br>clinical use | Same |
| Indications for<br>use | Zirkonzahn<br>COLOUR<br>LIQUID is used for<br>coloring pre-sintered<br>zirconia structures. | ArgenZ Liquids are<br>intended to be used<br>by trained dental<br>technicians as an<br>accessory for<br>shading ArgenZ<br>frameworks and<br>ArgenZ allzirconia,<br>monolithic<br>restorations for<br>anterior and<br>posterior dental<br>prosthetics. | Similar |
| Chemical<br>Composition | Aqueous solutions of<br>transition and<br>lanthanoid metal salts | Aqueous solutions of<br>transition and<br>lanthanoid metal<br>salts | Similar |
| Biocompatibility | Established | Established | Same |
| Principles of<br>Operation | Brushing or<br>Dipping<br>Technique | Brushing or Dipping<br>Technique | Same |
| Type of<br>Packaging and<br>Volume | Bottle; 20 ml,<br>50 ml,<br>100 ml | Bottle; 30 ml, 100 ml | Similar |
| Shade | Various, including A1-<br>D4 | Various, including<br>A1-D4 | Similar |
| Storage<br>Conditions | Max. 25 °C<br>5 years | 25 - 75 °C<br>2 years | Minor<br>difference |

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.

{7}------------------------------------------------

# 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.