Coloring Liquid

K192723 · Aidite (Qinhuangdao) Technology Co., Ltd. · EIH · Aug 18, 2020 · Dental

Device Facts

• Record ID: K192723
• Device Name: Coloring Liquid
• Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Aug 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.

Device Story

Coloring Liquid is a water-based, acidic metal salt solution used in dental laboratories. It is applied to zirconia ceramic frameworks or restorations via brushing or immersion prior to the final high-temperature sintering process. The liquid allows dental technicians to adjust the shade of the zirconia to match a patient's natural tooth color. The device is non-sterile and intended for professional use by dental clinicians or technicians. By enabling precise color matching, the device improves the aesthetic outcome of dental restorations for the patient.

Clinical Evidence

Bench testing only. Biocompatibility testing was conducted per ISO 10993 standards, including cytotoxicity (ISO 10993-5:2009), oral mucosa irritation (ISO 10993-10:2010), sensitization (ISO 10993-10:2010), subchronic toxicity (ISO 10993-11:2006), and genotoxicity (ISO 10993-3:2003). Results showed no adverse effects.

Technological Characteristics

Water-based solution containing inorganic salts, polyethylene glycol, and polydextrose. Non-sterile. Applied via brush or immersion. Operates as a chemical staining agent for zirconia ceramics prior to sintering.

Indications for Use

Indicated for the complete or partial coloration of zirconia ceramic materials used in dental restorations.

Regulatory Classification

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.

Predicate Devices

• Upcera Coloring Liquid (I and II) (K141723)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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,<br>Qinhuangdao City China |
| Phone No. | [phone] |
| Fax No. | [phone] |
| Contact person | Zhang Wei |
| Contact person's e-mail | [e-mail] |
| 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,<br>Xili Town, Nanshan District, Shenzhen, Guangdong Province, China |
| | Phone No. |
| Contact person | Field Fu; |
| Contact person's e-mail | [e-mail];[e-mail] |
| 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 |

- 4. 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:<br>Coloring Liquid | Primary Predicate Device:<br>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:<br>Water, Polyethylene glycol, HCl, inorganic salts<br>Upcera Coloring Liquid II:<br>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<br>Toxicity(ISO<br>10993-11:2006) | No subchronic toxic effects<br>observed | No subchronic toxic effects<br>observed | Same |
| Genotoxicity<br>( ISO10993-3:20<br>03) | No genotoxic effects<br>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.