Dental Zirconia Blank & Coloring Liquid
Device Facts
| Record ID | K261046 |
|---|---|
| Device Name | Dental Zirconia Blank & Coloring Liquid |
| Applicant | Hunan Qinghao Puzhong Technology Co., Ltd. |
| Product Code | EIH · Dental |
| Decision Date | Jul 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6660 |
| Device Class | Class 2 |
Indications for Use
Dental Zirconia Blank & Coloring Liquid are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. The Coloring Liquid is used for coloring pre-sintered zirconia structures.
Device Story
Device consists of zirconia blanks and coloring liquids for dental restorations. Blanks are zirconia-based ceramic blocks/discs; processed via CAD/CAM or manual milling in dental labs. Coloring liquid applied to pre-sintered zirconia structures to achieve desired shade/translucency. Final restoration sintered in oven to harden ZrO2. Output is a custom dental prosthetic (crown, bridge, veneer, inlay/onlay). Used by dental professionals to restore tooth function/aesthetics. Benefits include patient-specific anatomical fit and aesthetic matching.
Clinical Evidence
No clinical data. Bench testing only. Performance verified per ISO 6872-2024 (appearance, radioactivity, flexural strength, chemical solubility, thermal expansion, density). Biocompatibility testing per ISO 10993-1:2018 and ISO 7405:2025 (cytotoxicity, irritation, sensitization, acute/subchronic toxicity, genotoxicity, implantation) confirms safety.
Technological Characteristics
Materials: Zirconia (ZrO2, Y2O3, HfO2 >99.0%) with inorganic pigment additives (<=1.0wt%). Coloring liquid: Water, polyethylene glycol, inorganic salts. Form factor: Blocks, discs, custom shapes. Processing: CAD/CAM milling followed by sintering (>1500°C). Standards: ISO 6872-2024. Non-sterile. Single-use.
Indications for Use
Indicated for dental restorations (crowns, bridges, veneers, inlays/onlays) in patients requiring prosthetic dental devices. Processed by dental laboratories or professionals using CAD/CAM or manual milling. No specific contraindications listed.
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 Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K141724)
Reference Devices
- Upcera Coloring Liquid (K141723)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 17, 2026
Hunan Qinghao Puzhong Technology Co., Ltd.
% Yuqing Yang
RA specialist
Beijing Xinranyicheng Medicine & Technology Co., Ltd.
2-801-01, Floor 7, Bldg. 1, #168 Guanganmenwai St., Xicheng District, Beijing
Beijing, Beijing 10053
CHINA
Re: K261046
Trade/Device Name: Dental Zirconia Blank & Coloring Liquid
Regulation Number: 21 CFR 872.6660
Regulation Name: Porcelain Powder For Clinical Use
Regulatory Class: Class II
Product Code: EIH
Dated: July 13, 2026
Received: July 14, 2026
Dear Yuqing Yang:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/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 -S
Michael E. Adjodha, MChE, RAC, CQIA
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K261046
Device Name
Dental Zirconia Blank & Coloring Liquid
Indications for Use (Describe)
Dental Zirconia Blank & Coloring Liquid are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. The Coloring Liquid is used for coloring pre-sintered zirconia structures.
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)
**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.\***
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
# I. GENERAL INFORMATION
K261046
Applicant:
Hunan Qinghaopuzhong Technology Co., Ltd.
1-3F, Building 2.2-F, Xinma Power Innovation Park, No.899 Xianyue Ring Road, Majiahe Street,
Tianyuan District, Zhuzhou City, Hunan Province, 412007, China
Zip code:412000
Zhiquan Wang
Phone:86 - 731 - 28700818
E-Mail:www.matovix.com
Contact Person:
Yang YuQing
Phone:+86-18603302976
E-Mail:xinran152@xinranmed.com
Date Prepared: July 9,2026
# II. DEVICE INFORMATION
510(K) Number: K261046
Trade Name: Dental Zirconia Blank & Coloring liquid
Common Name : Porcelain Powder for Clinical Use
Classification Name: Porcelain Powder for Clinical Use
Regulation Number: 21 CFR 872.6660
Regulatory Class: Class II
Product Code: EIH
Classification Panel :Dental
Type of 510(k) submission: Traditional
# PREDICATE DEVICE INFORMATION
Primary Predicate Device :
510(k) Summary
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
510(K) Number:K141724
Trade Name:Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Submitter/Manufacturer:Liaoning Upcera Company Limited
# **Reference Device:**
510(K) Number: K141723
Trade Name:Upcera Coloring Liquid
Submitter/Manufacturer:Liaoning Upcera Company Limited
### III. DEVICE DESCRIPTION
Dental Zirconia Blank are derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are further fabricated into various all-ceramic restorations such as crowns, bridges, veneers, and inlay/onlay. The zirconia powder is composed of ZrO₂, HfO₂, Y₂O₃, and other oxides; the performance of the Dental Zirconia Blanks and the colored Dental Zirconia Blanks using Coloring Liquid conform to ISO 6872-2024, Dentistry: Ceramic Materials. The Coloring Liquid is used for coloring pre-sintered zirconia structures.
Dental Zirconia Blank are ceramic dental blanks designed to manufacture ceramic dental prosthetic devices. These devices are fabricated using CAD/CAM machining processes. All prosthetic dental devices are intended for single-use applications. At the dental lab, the blanks are held to the CAD/CAM machine, which is used to machine the final dental restoration. After the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO₂ to achieve its final properties.
Dental Zirconia Blank are supplied in different shapes, such as blocks, discs or customized shapes. They are provided in combinations of ninety-nine different colors and a gradual-changing translucency effect. The different shades originate from the different constituents of color additives (such as Fe₂O₃ and Er₂O₃); the different translucencies originate from a slight difference in the amount of Y₂O₃. Additionally, The white Dental Zirconia Blanks in models MT, ST, UT, and ET can be colored to different shades with corresponding liquids LMT, LST, LUT, and LET.
510(k) Summary
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission---
#### **IV. INDICATIONS FOR USE**
Dental Zirconia Blank & Coloring Liquid are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. The Coloring Liquid is used for coloring pre-sintered zirconia structures.
#### **V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE**
The following table shows similarities and differences in use, design, and material between the subject Device and the predicate devices (Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank[K141724] and Upcera Coloring Liquid[K141723]).
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
| Description | Subject Device | Primary Predicate Device | Reference Device | Comparison |
| --- | --- | --- | --- | --- |
| 510K Number | K261046 | K141724 | K141723 | - |
| Product Code | EIH | EIH | EIH | Same |
| Proprietary Name | Dental Zirconia Blank & Coloring liquid | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Upcera Coloring Liquid | - |
| Manufacturer | Hunan Qinghaopuzhong Technology Co., Ltd. | Liaoning Upcera Company Limited | Liaoning Upcera Company Limited | - |
| Indications for use | Dental Zirconia Blank & Coloring Liquid are used for dental restorations using different CAD/CAM or manual milling machines.All blanks are processed through dental laboratories or by dental professionals.The Coloring Liquid is used for coloring pre-sintered zirconia structures. | Upcera Dental Zirconia Blanks & Dental Zirconia Pre-Shaded Blanks are used for dental restorations using different CAD/CAM or manual milling machines.All blanks are processed through dental laboratories or by dental professionals. | 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:The subject device includes both dental zirconia blank and coloring liquid. The intended use of each constituent is the same as that of its corresponding predicate device. |
| Basic Design | Blocks and disc | Blocks,disc, and rod | / | Same |
510(k) Summary
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
| Materials | Dental Zirconia Blank | Zirconia(\( ZrO_{2}+Y_{2}O_{3}+HfO_{2} \) >99.0%)Inorganic pigments*≤1.0wt% | Regular:Zirconia(\( ZrO_{2}+Y_{2}O_{3}+HfO_{2}+Al_{2}O_{3} \) ≥99.0%)Pre-Shaded:Zirconia(\( ZrO_{2}+Y_{2}O_{3}+HfO_{2}+Al_{2}O_{3} \) ≥98.0%)Inorganic pigments(\( Fe_{2}O_{3},Pr_{2}O_{3} \) and \( Er_{2}O_{3} \)) <2.0% | / | Equivalent\( ^{1} \) |
| --- | --- | --- | --- | --- | --- |
| | Coloring Liquid | Water, Polyethylene glycol, inorganic salts | / | Upcera Coloring Liquid I:Water, Polyethylene glycol, HCl, inorganic saltsUpcera Coloring Liquid II:Water, Polydextrose, inorganic salts | Equivalent\( ^{2} \) |
| Processing | Dental Zirconia Blank | Sintering at temperature >1500°C | Sintering at temperature >1500°C | / | Same |
| Dimension | Dental Zirconia Blank | Various | Various | / | Same |
| Single Use | | Yes | Yes | Yes | Same |
| Shade | Dental Zirconia Blank | Ninety nine colors and gradual changing translucencies effect. | None,and Pre-shaded(for pre-shaded series) | / | Equivalent:There are Slightly different colors, but it doesn’t raise different questions of safety and |
510(k) Summary
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
| | | | | | effectiveness than the predicate device. |
| --- | --- | --- | --- | --- | --- |
| | Coloring Liquid | Various | / | Various | Same |
| Sterile | | Non-sterile | Non-sterile | Non-sterile | Same |
*: The Inorganic pigments mentioned in the Subject Device are consistent with the descriptions of Other oxides, which may contain \( Al_{2}O_{3} \) , \( Fe_{2}O_{3} \) , \( Er_{2}O_{3} \) , etc, with the content \( \leq1wt\% \) .
Our device's indication for use, design, material, and processing are essentially identical to the predicate device. Minor differences pose no safety or effectiveness concerns. The minor differences are as follows:
Note 1: The subject device's Dental Zirconia Blank contains \(\mathrm{ZrO_2 + Y_2O_3 + HfO_2}\) at \(>99.0\%\), with other oxides \((\mathrm{Al_2O_3}, \mathrm{Fe_2O_3}, \mathrm{Er_2O_3}, \mathrm{etc.})\) at \(\leqslant 1.0\mathrm{wt}\%\). The predicate device(K141724) combines \(\mathrm{ZrO_2 + Y_2O_3 + HfO_2 + Al_2O_3}\) at \(\geqslant 99.0\%\) (regular) or \(\geqslant 98.0\%\) (pre-shaded), with \(\mathrm{Fe_2O_3}\), \(\mathrm{Pr_2O_3}\), and \(\mathrm{Er_2O_3}\) additives. These compositional variations are minor and within industry standards; biocompatibility testing confirms equivalent safety.
Note 2: The subject device's Coloring Liquid is similar to the predicate device(K141723), the main components are water, ethylene glycol and inorganic salts, and the predicate device also contains acid (HCl), but it is not the main component and will evaporate during sintering, so the lack of this component will not affect the use of the subject device. All the metal nitrates we use have long-term safety characteristics, and we have tested the biocompatibility of the dyed zirconia ceramic final products, and the results show that the subject device will not cause any safety problems.
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
## VI. Summary of Non-Clinical Testing
Performance testing has been carried out to demonstrate that the Dental Zirconia Blanks and the colored Dental Zirconia Blanks using Coloring Liquid meet the performance specifications for its intended use. The following tests were performed on the device.
- ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials.
All tests were verified to meet acceptance criteria. The subject device's test results on appearance, radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, and sintered density are very similar to those of the predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials used.
According to ISO 10993-1:2018 and ISO 7405:2025, we evaluated and conducted the compatibility test for the proposed device. The following table shows the biocompatibility testing results.
| Item | Proposed device | Primary Predicate Device(K141724) Reference Device(K141723) |
| --- | --- | --- |
| Cytotoxicity | No cytotoxicity effect. (ISO 10993-5:2009) | No cytotoxicity effect. (ISO 10993-5:2009) |
| Oral Mucosa Irritation | The test result of oral mucosa irritation showed that the response category of the test article extract in the golden hamster was None (SC) and None (CO). (ISO 10993-23:2021) | Not a primary oral mucosa irritant under the conditions of the study. (ISO 10993-10:2010) |
| Sensitization | The sample extract showed no significant evidence of causing skin sensitization in the guinea pig. (ISO 10993-10:2021) | Not a sensitizer under the conditions of the study (ISO 10993-10:2010) |
| Acute Toxicity/Subacute toxic | The test article showed no significant evidence of causing acute systemic toxicity in the mouse. (ISO 10993-11:2017) | No subacute toxic effects observed (ISO 10993-11:2017) |
| Subchronic Toxicity | No subchronic toxic effects observed (ISO 10993-11:2017) | No subchronic toxic effects observed (ISO 10993-11:2017) |
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Hunan Qinghaopuzhong Technology Co., Ltd.
[Dental Zirconia Blank & Coloring Liquid] 510(k) Submission
| Genotoxicity Toxicity | No genotoxic effects observed.(ISO 10993-3:2014) | No genotoxic effects observed.(ISO 10993-3:2014) |
| --- | --- | --- |
| Implantation | No reaction to the subcutaneous tissue in rabbit after implantation of 26 weeks(ISO 10993-6:2016) | - |
Note: Testing was performed on ET-W zirconia blanks that were stained with LET-SQ coloring liquid and subjected to final sintering.
## VII. Clinical Test Conclusion
No clinical study is included in this submission
## VIII. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device Dental Zirconia Blank & Coloring Liquid performs as well as or better than the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (primary predicate device) and K141723 Upcera Coloring Liquid (Reference Device). Dental Zirconia Blank & Coloring Liquid is substantially equivalent to the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (primary predicate device) and K141723 Upcera Coloring Liquid (Reference Device).
According to the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, the subject device is substantially equivalent to the predicate device.
510(k) Summary
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