(227 days)
No
The device description and performance studies focus on the chemical and physical properties of a coloring solution for dental zirconia, with no mention of AI or ML technologies.
No
The device is described as an "Esthetic Colorant" used for "coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations." Its purpose is to adjust the color shade of dental restorations, which is an aesthetic function rather than a therapeutic one. The description focuses on its chemical composition and application for color adjustment in dental materials, not on treating or preventing diseases or conditions.
No
Explanation: The device, Esthetic Colorant, is used for coloring pre-sintered zirconia structures for dental restorations. Its function is to modify the aesthetic appearance (color) of these structures, not to diagnose any medical condition or disease.
No
The device is a physical colorant solution used to modify the color of zirconia structures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations." This is a process used in the creation of dental prosthetics.
- Device Description: The device is a "dilute aqueous solution of transition metal salts and lanthanoid metal salts" used to color zirconia structures.
- Function: Its function is to adjust the color shade of the zirconia structure during the fabrication process.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not interact with biological samples.
- User: The intended users are "professional technicians in the field of dentistry," not medical professionals performing diagnostic tests.
The device is a material used in the manufacturing of dental restorations, which falls under the category of dental devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Esthetic Colorant, a colorant with a zirconia structure, is a dilute aqueous solution of transition metal salts and lanthanoid metal salts and enables appropriate color adjustment when combined with a pre-sintered zirconia structure such as KATANA Zirconia (K143439).
Esthetic Colorant colors the pre-sintered zirconia structure by applying it with a metal-free brush. The structure is then dried and then sintered at temperatures above 1400°C. Sintering welds the coloring components in Esthetic Colorant, making it possible to adjust the color shade of the zirconia structure.
Esthetic Colorant has 12 shades in bottle size (12 ml). In addition, Esthetic Colorant can only be used by professional technicians in the field of dentistry.
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
Esthetic Colorant can only be used by professional technicians in the field of dentistry.
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 and chemical properties of the colored pre-sintered zirconia structures to demonstrate that the subject device of interest did not adversely affect the function of the zirconia structures. Since the product used for the evaluation is a dental zirconia structure, the physical and chemical properties were evaluated according to ISO 6872: 2015. As a result of the subject device does not have an adverse effect, so it is suitable for the purpose of use.
Summary of physical properties to the product standard (ISO 6872:2015)
Product: KATANA Zirconia (HT) - Flexural strength: Equal to or greater than 900MPa. Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (B plus) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (BROWN) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (ORANGE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (BLUE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (GRAY) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (VIOLET) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (OPAQUE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (PINK) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) - Coefficient of thermal expansion: The coefficient of thermal expansion of the ceramics shall not deviate by more than 0.5 ×10-6K-1 from the value stated by the manufacturer. Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (B plus) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (BROWN) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (ORANGE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (BLUE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (GRAY) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (VIOLET) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (OPAQUE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (PINK) - Test Result: COMPLIES
Summary of chemical properties to the product standard (ISO 6872:2015)
Product: KATANA Zirconia (HT) - Chemical solubility: Less than to 100µg/cm². Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (B plus) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (BROWN) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (ORANGE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (BLUE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (GRAY) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (VIOLET) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (OPAQUE) - Test Result: COMPLIES
Product: KATANA Zirconia (HT) Shaded with Esthetic Colorant (PINK) - Test Result: COMPLIES
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.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
September 23, 2022
Kuraray Noritake Dental Inc. Yasujiro Ohara Manager Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN
Re: K220369
Trade/Device Name: Esthetic Colorant Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH, Dated: August 24, 2022 Received: August 26, 2022
Dear Yasujiro Ohara:
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 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
1
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 mediation-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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K220369
Device Name Esthetic Colorant
Indications for Use (Describe)
Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.
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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3
Date: March 8, 2022
510(k) Summary
| 1. 510(k) submitters information | |
|---|---|
| 1) Name | Kuraray Noritake Dental Inc. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan |
| 3) Contact person | Yasujiro Ohara |
| Manager | |
| Quality Assurance Department | |
| 4) Contact person in USA | Manabu Suzuki |
| Director | |
| KURARAY AMERICA, INC. | |
| 32 Old Slip, 7th Floor, New York, NY 10005 | |
| Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 | |
| Fax: (212)-867-3543 |
2. Subject device identification
| 1) Trade / Proprietary name | Esthetic Colorant |
|---|---|
| 2) Common Name | Coloring liquid for zirconia structures |
| 3) Classification Number / Name | 21 CFR 872.6660 / Porcelain Powder for Clinical Use |
| 4) Class | II |
| 5) Product code | EIH |
| 6) Panel | Dental |
3. Legally marketed predicate device
| 1) Company | Zirkonzahn srl |
|---|---|
| 2) Device name | Zirkonzahn COLOUR LIQUID |
| 3) Common Name | Liquid for Dental Zirconia Prosthesis |
| 4) Classification Number / Name | 21 CFR 872.6660 / Porcelain Powder for Clinical Use |
| 5) Class | II |
| 6) Product code | EIH |
| 7) Panel | Dental |
| 8) 510(k) Number | K190518 |
4. Device description
Esthetic Colorant, a colorant with a zirconia structure, is a dilute aqueous solution of transition metal salts and lanthanoid metal salts and enables appropriate color adjustment when combined with a pre-sintered zirconia structure such as KATANA Zirconia (K143439).
Esthetic Colorant colors the pre-sintered zirconia structure by applying it with a metal-free brush. The structure is then dried and then sintered at temperatures above 1400°C. Sintering welds the coloring components in Esthetic Colorant, making it possible to adjust the color shade of the zirconia structure.
Esthetic Colorant has 12 shades in bottle size (12 ml). In addition, Esthetic Colorant can only be used by professional technicians in the field of dentistry.
5. Indications for Use / Intended Use
Esthetic Colorant is used for coloring pre-sintered zirconia structures for the fabrication of all-ceramic restorations.
6. Performance data
Non-clinical testing was performed to evaluate the physical and chemical properties of the colored pre-sintered zirconia structures to demonstrate that the subject device of interest did not adversely affect the function of the zirconia structures. Since the product used for the evaluation is a dental zirconia structure, the physical and chemical properties were evaluated according to ISO 6872: 2015. As a result of the subject device does not have an adverse effect, so it is suitable for the purpose of use.
4
7. Performance data summary
7-1. Summary of physical properties to the product standard (ISO 6872:2015)
| Product | Flexural strength | Test Result | Product | Coefficient of thermal expansion | Test Result |
|---|---|---|---|---|---|
| KATANA Zirconia (HT) | Equal to or greater than 900MPa. | COMPLIES | KATANA Zirconia (HT) | The coefficient of thermal expansion of | |
| the ceramics shall not deviate by more | |||||
| than $0.5 ×10^{-6}K^{-1}$ from the value stated | |||||
| by the manufacturer. | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (B plus) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (B plus) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (BROWN) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (BROWN) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (ORANGE) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (ORANGE) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (BLUE) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (BLUE) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (GRAY) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (GRAY) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (VIOLET) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (VIOLET) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (OPAQUE) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (OPAQUE) | COMPLIES | ||||
| KATANA Zirconia (HT) | |||||
| Shaded with Esthetic Colorant (PINK) | COMPLIES | KATANA Zirconia (HT) | |||
| Shaded with Esthetic Colorant (PINK) | COMPLIES |
7-2. Summary of chemical properties to the product standard (ISO 6872:2015)
| Product | Chemical solubility | Test Result |
|---|---|---|
| KATANA Zirconia (HT) | Less than to 100µg/cm². | COMPLIES |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (B plus) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (BROWN) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (ORANGE) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (BLUE) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (GRAY) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (VIOLET) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (OPAQUE) | COMPLIES | |
| KATANA Zirconia (HT) | ||
| Shaded with Esthetic Colorant (PINK) | COMPLIES |
5
| 8. Substantial Equivalence Discussion | |||
|---|---|---|---|
| Properties | |||
| and information | Subject device: | ||
| Esthetic Colorant | Predicate device: (K190518) | ||
| Zirkonzahn COLOUR LIQUID | Comparison | ||
| comments | |||
| Company | Kuraray Noritake Dental Inc. | Zirkonzahn srl | — |
| Product code | EIH | EIH | Same |
| Regulation name | |||
| (Regulation No.) | Porcelain powder for clinical use | ||
| (872.6660) | Porcelain powder for clinical use | ||
| (872.6660) | Same | ||
| Indications for use/ | |||
| Intended use | Esthetic Colorant is used for | ||
| coloring pre-sintered zirconia | |||
| structures for the fabrication of | |||
| all-ceramic restorations. | Zirkonzahn COLOUR LIQUID is | ||
| used for coloring pre-sintered | |||
| zirconia structures. | Similar | ||
| Technology | Aqueous solutions of transition | ||
| and lanthanoid metal salts. | Aqueous solutions of transition | ||
| and lanthanoid metal salts. | Similar | ||
| Chemical | |||
| composition | A solvent consisting mostly of | ||
| water. | |||
| A solute consisting of transition | |||
| and lanthanoid metal salts. | |||
| Other chemical ingredients. | A solvent consisting mostly of | ||
| water. | |||
| A solute consisting of transition | |||
| and lanthanoid metal salts. | Minor | ||
| difference | |||
| (Note 5-8-1.) | |||
| Operating | |||
| principle | Brush zirconia ceramic structures | ||
| with coloring liquid before | |||
| sintering | Brush or immerse zirconia | ||
| ceramic structures with coloring | |||
| liquid before sintering | Similar | ||
| Type of packaging | |||
| and volume | Bottle; 12 ml | Bottle; 20 ml, 50 ml, 100 ml | Similar |
| Shade | Various | Various | Similar |
| Storage conditions | Max: 30°C, 2 years | Max: 25°C, 5 years | Minor |
| difference | |||
| (Note 5-8-2.) | |||
| Sterile | Non-sterile | Non-sterile | Same |
| Biocompatibility | Established | ||
| (the worst case biocompatibility | |||
| with ISO 10993-1:2018) | Established | ||
| (the worst case biocompatibility | |||
| with ISO 10993-1:2010) | Similar | ||
| (Note 5-8-3.) |
0 C--latoration Lia---------
8-1. Discussion of chemical composition
The subject device and the predicate device are the same in that they are aqueous solutions of transition metal salts and lanthanoid metal salts. As the subject device contains other chemical ingredients, we evaluated the biocompatibility of the subject device in combination with 510(k) cleared dental zirconia and confirmed that these differences of chemical composition did not affect the biological safety of the subject device.
8-2. Discussion of storage conditions
In order to establish the storage conditions of the subject device, the test sample was accelerated and the requirements of ISO 6872:2015 was evaluated, and it was confirmed that there was no problem.
8-3. Established of biocompatibility
Biocompatibility was evaluated using the same ISO 10993-1 as the predicate device. Biocompatibility test was evaluated on the worst case model of the subject device as in the predicate device, and it was confirmed that the subject device satisfied biocompatibility.
9. Conclusion
The subject device and the predicate device are composed of similar chemical composition, and the difference does not matter. It was also confirmed that there was no problem with storage conditions and biocompatibility. From the above. it was judged that the two were substantially equivalent. In addition, from performance tests, the subject device serves its intended use.