(263 days)
Not Found
No
The summary describes a coloring liquid for dental zirconia and does not mention any AI or ML components or functionalities.
No.
The device is used for coloring dental materials (zirconia structures) and is not applied to a patient for therapeutic purposes. Its function is to modify the appearance of a prosthetic material, not to treat a disease or condition.
No
Explanation: The device is used for coloring pre-sintered zirconia structures in dentistry and does not involve any diagnostic function or analysis of medical conditions.
No
The device description clearly states it is a liquid used for coloring zirconia structures, which is a physical substance, not software.
Based on the provided information, the Zirkonzahn COLOUR LIQUID is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coloring pre-sintered zirconia structures." This is a process applied to a dental material (zirconia) used to create dental prosthetics.
- Device Description: The description details how the liquid is used to color the zirconia framework.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are specifically designed for these types of tests.
- User and Setting: The device is used by "specialized technicians" in the "dental field," which aligns with the creation of dental prosthetics, not diagnostic testing.
- Performance Studies: The performance studies focus on the physical properties of the colored zirconia and the shelf life/biocompatibility of the liquid itself, not on diagnostic accuracy or performance related to a biological sample.
- Predicate Devices: The predicate devices listed (ArgenZ Liquid Shade, etc.) are also coloring liquids for dental zirconia, further supporting its classification as a dental material processing aid, not an IVD.
In summary, the Zirkonzahn COLOUR LIQUID is a material used in the process of creating dental prosthetics. It does not perform any diagnostic function on a biological sample.
N/A
Intended Use / Indications for Use
Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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).
The devices are used in the dental field by specialized technicians only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices are used in the dental field by specialized technicians only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (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. |
|---|---|
| -------------------------------- | --------------------------------------------------------------------------------- |
| 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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3
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 Color |
| 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
B1, B2, B3, B4
C1, C2, C3, C4
D2, D3, D4
1M1, 1M2
2L1.5, 2M2
3M2, 3M3
4M2 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| VITA Bleach shades | 0M1, 0M2, 0M3 |
| ZZ Intensive shades | Tissue A, Tissue B, Tissue C
Orange 1, Brown 2
Incisal grey, Incisal violet, Incisal blue
LuNe
A-Cervical, B-Cervical, C-Cervical, D-Cervical |
| ZZ Special liquids | Translucent
Opaque
Fluorescence |
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 Prettau
Aquarell - Translucent | Evaluated |
| Colour Liquid Prettau
Aquarell - Opaque | Evaluated |
| Thinner | Evaluated |
| Stabilizer | Evaluated |
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SUBSTANTIAL EQUIVALENCE
| | Zirkonzahn
COLOUR LIQUID
(new devices) | ArgenZ Liquids
(K182833) | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Zirkonzahn srl | The Argen Corporation | |
| Product Code | EIH | EIH | Same |
| Regulation
Number | 872.6660 | 872.6660 | Same |
| Regulation
Name | Porcelain powder for
clinical use | Porcelain powder for
clinical use | Same |
| Indications for
use | Zirkonzahn
COLOUR
LIQUID is used for
coloring pre-sintered
zirconia structures. | ArgenZ Liquids are
intended to be used
by trained dental
technicians as an
accessory for
shading ArgenZ
frameworks and
ArgenZ allzirconia,
monolithic
restorations for
anterior and
posterior dental
prosthetics. | Similar |
| Chemical
Composition | Aqueous solutions of
transition and
lanthanoid metal salts | Aqueous solutions of
transition and
lanthanoid metal
salts | Similar |
| Biocompatibility | Established | Established | Same |
| Principles of
Operation | Brushing or
Dipping
Technique | Brushing or Dipping
Technique | Same |
| Type of
Packaging and
Volume | Bottle; 20 ml,
50 ml,
100 ml | Bottle; 30 ml, 100 ml | Similar |
| Shade | Various, including A1-
D4 | Various, including
A1-D4 | Similar |
| Storage
Conditions | Max. 25 °C
5 years | 25 - 75 °C
2 years | Minor
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.
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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.