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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Coloring Liquid." This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the format typically used for AI/ML-based diagnostic devices.

Therefore, many of the requested sections (acceptance criteria for a diagnostic device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size, standalone performance, ground truth types) are not applicable or not provided in this regulatory submission.

The document primarily addresses the safety and effectiveness of the Coloring Liquid through comparison to a legally marketed predicate device and non-clinical bench testing.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available:

Device Name: Coloring Liquid

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

For this device, the "acceptance criteria" are primarily based on demonstrating similar properties and performance to the predicate device, particularly regarding safety (biocompatibility) and functional characteristics (coloration of zirconia). Specific quantitative performance metrics typical of diagnostic devices are not present.

Acceptance Criteria (Bench Testing/Biocompatibility)	Reported Device Performance
Biocompatibility:
Cytotoxicity (ISO 10993-5:2009): No cytotoxicity effect	No cytotoxicity effect
Oral Mucosa Irritation (ISO 10993-10:2010): Not a primary oral mucosa irritant	Not a primary oral mucosa irritant under the conditions of the study
Sensitization (ISO 10993-10:2010): Not a sensitizer	Not a sensitizer under the conditions of the study
Subchronic Toxicity (ISO 10993-11:2006): No subchronic toxic effects	No subchronic toxic effects observed
Genotoxicity (ISO 10993-3:2003): No genotoxic effects	No genotoxic effects observed
Functional Equivalence:
Intended Use: Complete or partial coloration of zirconia ceramic materials	Same as predicate
Technology: Water based with inorganic pigments	Same as predicate
Operating Principle: Brush or immerse zirconia ceramic materials with coloring liquid before sintering	Same as predicate
Ingredient similarity (minor differences evaluated)	Similar, with a minor difference in dispersant (polyethylene glycol) deemed safe and not reacting with other ingredients.
Non-clinical testing met specifications	All tests were verified to meet acceptance criteria (specific criteria not detailed for coloration performance)

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

Sample size: Not specified. The document states "Bench testing was performed" and "Biocompatibility testing was performed," but does not detail the number of samples or specimens used for these tests.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). These are non-clinical (bench and biocompatibility) tests, not clinical data from patients.

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

Not applicable. This is not a diagnostic device involving expert interpretation of medical images or data. The "ground truth" for biocompatibility is established by standardized ISO testing protocols.

4. Adjudication method for the test set

Not applicable. There is no human adjudication process described for the non-clinical tests.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

For biocompatibility, the "ground truth" is defined by the results of standardized ISO 10993 series tests (e.g., cytotoxicity, irritation, sensitization, subchronic toxicity, genotoxicity). For functional aspects (coloration), the ground truth is implicitly based on achieving the intended aesthetic effect on zirconia, but specific quantitative metrics or expert evaluations of color matching are not detailed in this summary.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a training set.

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

Not applicable.

Summary

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

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

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

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

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

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)

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 PRAStaff@fda.hhs.gov

"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}------------------------------------------------

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

1. Device Description

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

Product: Coloring Liquid

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 saltsUpcera 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.

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

Product: Coloring Liquid

10993-10:2010)
SubchronicToxicity(ISO10993-11:2006)	No subchronic toxic effectsobserved	No subchronic toxic effectsobserved	Same
Genotoxicity( ISO10993-3:2003)	No genotoxic effectsobserved	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.

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.