(175 days)
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
Coloring Liquid is water based, 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. Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures
The provided documentation is a 510(k) summary for a medical device called "Coloring Liquid." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human subjects or complex algorithms.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding sample sizes, expert ground truth, adjudication methods, multi-reader studies, and training sets are not applicable to this type of submission. This document describes a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document reports and compares safety testing results, which can be interpreted as demonstrating that the device meets acceptance criteria for biocompatibility.
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) | Reported Device Performance (Predicate Device K141723) |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa (ISO 10993-10: 2010) | Not a primary oral mucosa irritant | Not a primary oral mucosa irritant under the conditions of the study | 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 | Not a sensitizer under the conditions of the study |
| Acute Systemic Toxicity and Subchronic Toxicity (ISO 10993-11: 2006) | No acute and subchronic toxic effects observed | No Acute Systemic Toxicity and subchronic toxic effects observed | No acute and subchronic toxic effects observed |
| Genotoxicity (ISO 10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed | No genotoxic effects observed |
Study Proving Device Meets Acceptance Criteria:
The document states: "Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used."
This indicates that internal bench tests and specific biocompatibility tests, following ISO 10993 standards, were conducted to demonstrate the safety of the device. The results of these biocompatibility tests are summarized in Table 5.2. The conclusion drawn is that the subject device's performance in these safety tests is comparable to the predicate device, thus meeting the implied safety acceptance criteria for this type of product.
2. Sample Size Used for the Test Set and the Data Provenance:
- Not Applicable. This submission is for a material (coloring liquid) and focuses on biocompatibility and physicochemical properties, not a diagnostic or AI-powered imaging device that would require a "test set" of patient data in the typical sense. Biocompatibility tests are usually conducted on material samples in controlled laboratory settings (e.g., cell cultures, animal models as per ISO standards). The document does not specify the number of samples or specific animal models used, but refers to ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. Ground truth, in the context of device performance, typically refers to a definitive diagnosis or outcome for diagnostic/prognostic devices. For a coloring liquid, "ground truth" would relate to the chemical composition, color properties, and biocompatibility, which are verified through objective scientific methods and established ISO standards, not expert consensus in a clinical reading scenario.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no "test set" in the context of clinical interpretation, no adjudication method is relevant. Biocompatibility test results are typically interpreted by qualified laboratory personnel following established protocols.
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. The device is a "Coloring Liquid" for dental zirconia, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. The device is a chemical product, not an algorithm.
7. The Type of Ground Truth Used:
- Objective Test Results / Standardized Biocompatibility Assays. For this device, the "ground truth" for proving safety and effectiveness (as understood in this context) comes from the results of standardized laboratory tests (e.g., cytotoxicity assays, irritation tests, sensitization tests, systemic toxicity tests, genotoxicity assays) conducted according to recognized international standards (ISO 10993 series). These tests provide objective data on the biological responses to the material.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is not an AI/ML device that requires a training set.
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June 29, 2022
Dongguan Xiangtong Co., Ltd. Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K220017
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 28, 2022 Received: June 3, 2022
Dear Charles Shen:
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.
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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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Coloring Liguid
Indications for Use (Describe)
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
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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K220017 Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
DONGGUAN XIANGTONG CO., LTD NO.4. Tech 9th Rd, Hi-Tech Industrial Development Zone, Songshan Lake, Dongguan, Guangdong, China., Zipcode 523000 Tel: (086)-0769-22895688 Submitter's FDA Registration Number: N/A
Contact Person 5.2
Image /page/3/Picture/6 description: The image shows a logo for a company that appears to be in the medical field. The logo features a stylized letter 'M' in blue, with a crescent shape above it in light blue. The company name, "曼度医械", is written in orange above the 'M'. The overall design is simple and modern, with a focus on the company's initials.
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: December 19, 2021
| 5.4 | Device Name: |
|---|---|
| ----- | -------------- |
| Proprietary Name: | Coloring Liquid |
|---|---|
| Common Name: | Coloring Liquid |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: | Dental |
| Product Code: | EIH |
5.5 Predicate Device Information:
- K141723, "Upcera Coloring Liquid (I and II)", manufactured by "Liaoning (1) Upcera Co., Ltd." located in Benxi, China
5.6 Device Description:
Coloring Liquid is water based, 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.
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Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures
5.7 Indications for Use:
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
న్ని శిశు సంరక్షణ కేంద్రం, మూలాలు గ్రామం నుండి 10 కి.మీ. దూరంలో ఉంది. ప్రాథమిక ఆరోగ్యామ్ నిర్మాణ ప్రాథమిక ఆరోగ్యామ్ కూడా ఉంది. మాతా శిశు సంరక్షణ కేంద్రం, మూలాలు విశాఖపట్న Summary of Device Testing:
Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
5.9 Comparison With Predicate Device
Coloring Liquid is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- (1) K141723, "Upcera Coloring Liquid (I and II)", manufactured by "Liaoning Upcera Co., Ltd." located in Benxi, China
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K141723) |
|---|---|---|
| Indication forUse | Coloring Liquid is a liquid used for thecomplete or partial coloration of milledzirconia substructure and anatomy beforesintering. | Upcera Coloring Liquid (I and II) is aliquid used for the complete or partialcoloration of milled Upcera zirconiasubstructure and anatomy beforesintering. |
| Technology | Water based with inorganic pigments | Water based with inorganic pigments |
| OperatingPrinciple | Brush or immerse zirconia ceramic materialswith coloring liquid before sintering | Brush or immerse zirconia ceramicmaterials with coloring liquid beforesintering |
| Ingredient | Water, Polyethylene glycol, inorganic salts | Water, Polyethylene glycol, inorganicsalts |
| Bottle Size | Various | Various |
| Shade | Various | Various |
| Prescription | Yes | Yes |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
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| Sterile | Non-sterile | Non-sterile |
|---|---|---|
| --------- | ------------- | ------------- |
The subject device is similar to the predicate device in terms of indications for use, technology, and principle of operation.
The following table shows similarities and differences of the safety tesing between our device and the predicate devices.
Table 5.2: Comparison of Safety Testing
| Description | Subject Device | Predicate Device (K141723) |
|---|---|---|
| Cytotoxicity(ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral MucosaIrritation(ISO 10993-10: 2010) | Not a primary oral mucosairritant under the conditions ofthe study | Not a primary oral mucosairritant under the conditions ofthe study |
| Sensitization (ISO10993-10: 2010) | Not a sensitizer under theconditions of the study | Not a sensitizer under theconditions of the study |
| Acute Systemic Toxicityand Subchronic Toxicity(ISO 10993-11: 2006) | No Acute Systemic Toxicity andsubchronic toxic effectsobserved | No acute and subchronic toxiceffects observed |
| Genotoxicity (ISO10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed |
5.10 Non-clinical Testing
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.
5.11 Conclusions
It has been shown in this 510(k) submission that "Coloring Liquid" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "Coloring Liquid" and their predicate device do not raise any question regarding its equivalence.
"Coloring Liquid", as designed and manufactured, is substantially equivalent as its predicate device.
§ 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.