(326 days)
Not Found
No
The device is a coloring liquid for dental restorations and the description focuses on its chemical composition and application method, with no mention of AI or ML.
No
This device is a coloring liquid used for dental zirconia materials and does not have any therapeutic function. It is used to adjust the color of dental restorations.
No
The device is a coloring liquid used to stain dental zirconia frameworks and restorations to match the natural color of a patient's teeth. It does not diagnose any medical condition or disease.
No
The device is a liquid used for coloring dental materials, which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to color zirconia ceramic materials for dental restorations. This is a material used outside the body to create a medical device (a dental restoration).
- Device Description: The description details a liquid used to stain dental zirconia frameworks prior to sintering. This process is part of the manufacturing or preparation of a dental device, not a test performed on a biological sample from a patient.
- Lack of Biological Sample Testing: IVDs are designed to test biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. This device does not interact with or analyze any biological samples.
The device is a material used in the creation of a dental prosthetic, which is a medical device, but the coloring liquid itself is not an IVD.
N/A
Intended Use / Indications for Use
Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.
Product codes
EIH
Device Description
Coloring liquid are water-based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth.
For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperature.
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
Not Found
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)
Bench testing was performed to ensure the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the substantially equivalent safety of the materials that are used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
August 18, 2020
Aidite (Qinhuangdao) Technology Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road, Nanshan District Shenzhen, 518000 CHINA
Re: K192723
Trade/Device Name: Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 12, 2020 Received: May 20, 2020
Dear Christy Young:
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
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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 (OS) 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,
for Srinivas "Nandu" Nandkumar, Ph.D. 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) K192723
Device Name Coloring Liquid
Indications for Use (Describe)
Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K192723
1. Contact Details
1.1 Applicant information
| Applicant Name | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address | No.9 Dushan Road, Economic and Technological Development Zone, |
| Qinhuangdao City China | |
| Phone No. | +86 335 8587898 |
| Fax No. | +86 335 8587198 |
| Contact person | Zhang Wei |
| Contact person's e-mail | zhangwei@zro2blocks.com |
| Date Prepared | Aug 18, 2020 |
| Website | www.zro2blocks.com |
1.2 Submission Correspondent
| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Image: 卓远天成 | 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, |
| Xili Town, Nanshan District, Shenzhen, Guangdong Province, China | |
| Phone No. | |
| Contact person | Field Fu; |
| Contact person's e-mail | christy@cefda.com;field@cefda.com |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Coloring Liquid |
|---|---|
| Common name | Coloring Liquid |
| Model | / |
| Classification | II |
| Classification name | Porcelain Powder for Clinical use |
| Product code | EIH |
| Regulation No. | 872.6660 |
Legally Marketed Predicate Device 3.
| Trade Name | Upcera Coloring Liquid (I and II) |
|---|---|
| 510(k) Number | K141723 (Primary Predicate Device) |
| Product Code | EIH |
| Manufacturer | Liaoning Upcera Co., Ltd |
-
- Device Description
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Product: Coloring Liquid
Coloring liquid are water-based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth.
For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperature.
5. Intended Use/Indication for Use
Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.
| Item | Proposed Device:
Coloring Liquid | Primary Predicate Device:
Upcera Coloring Liquid (I and II) (K141723) | Comments |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product Code | EIH | EIH | Same |
| Intended Use | Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials. | Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering. | Same |
| Technology | Water based with inorganic pigments | Water based with inorganic pigments | Same |
| Operating Principle | Brush or immerse zirconia ceramic materials with coloring liquid before sintering | Brush or immerse zirconia ceramic materials with coloring liquid before sintering | Same |
| Ingredient | Water, polyethylene glycol, Polydextrose, inorganic salts | Upcera Coloring Liquid I:
Water, Polyethylene glycol, HCl, inorganic salts
Upcera Coloring Liquid II:
Water, Polydextrose, inorganic salts | Similar, Note 1 |
| Bottle size | Various | Various | Same |
| Shade | Various | Various | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect | Same |
| Irritation Oral Mucosa Irritation (ISO 10993-10:2010) | Not a primary oral mucosa irritant under the conditions of the study | Not a primary oral mucosa irritant under the conditions of the study | Same |
| Sensitization(IS O | Not a sensitizer under the conditions of the study | Not a sensitizer under the conditions of the study | Same |
Substantial Equivalence Comparison 6.
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Product: Coloring Liquid
| 10993-10:2010) | |||
|---|---|---|---|
| Subchronic | |||
| Toxicity(ISO | |||
| 10993-11:2006) | No subchronic toxic effects | ||
| observed | No subchronic toxic effects | ||
| observed | Same | ||
| Genotoxicity | |||
| ( ISO10993-3:20 |
-
| No genotoxic effects
observed | No genotoxic effects observed | Same |
Note 1:
It is similar with the predicate device that water, Polydextrose and inorganic salts are the main ingredients. The minor difference between the proposed device and the predicate device, Upcera Coloring Liquid II, is that the proposed device contains polyethylene glycol. Polyethylene glycol, which is also a ingredient of the predicate device Upcera Coloring Liquid I, is a safe dispersant and does not react with the other ingredients. This difference will not cause any safety issues and we have conducted biocompatibility testing with the products.
7. Non-clinical Testing
Bench testing was performed to ensure the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the substantially equivalent safety of the materials that are used.
8. Conclusion
It has been shown in this 510(k) submission that Coloring Liquid and its predicate devices have the similar indications for use, technology, principle of operation, similar composition and biocompatibility.
The difference between Coloring Liquid and its predicate device do not raise any question regarding its safety and effectiveness.
Coloring Liquid, as designed and manufactured, is as safe and effective as its predicated device, and therefore is substantially equivalent as its predicate device.