Zirconia Dental Ceramics

K214005 · Shenzhen Yurucheng Dental Materials Co., Ltd. · EIH · Feb 18, 2022 · Dental

Device Facts

• Record ID: K214005
• Device Name: Zirconia Dental Ceramics
• Applicant: Shenzhen Yurucheng Dental Materials Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Feb 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

Device Story

Zirconia Dental Ceramics are yttria-stabilized zirconia blocks (ZrO2, HfO2, Y2O3, Al2O3) used for dental restorations. Dental professionals or laboratories use CAD/CAM or manual milling machines to shape blocks into crowns, bridges, veneers, inlays, or onlays based on patient anatomy. The device is provided non-sterile for single use. It serves as a restorative material to replace missing or damaged tooth structure, potentially improving patient oral function and aesthetics. No software or electronic components are involved in the device itself.

Clinical Evidence

No clinical data. Bench testing only. Performance testing per ISO 6872:2015 confirmed flexural strength (1076.4 MPa), fracture toughness (16.32 MPa*m1/2), and chemical solubility (54.2 µg/cm²). Biocompatibility testing per ISO 7405:2018 and ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation) showed no adverse effects.

Technological Characteristics

Material: Yttria-stabilized zirconia (ZrO2+HfO2+Y2O3 ≥99%, Y2O3 4.5-6.0%, Al2O3 ≤0.5%). Form factor: Cylinder, cuboid, U-shape blocks. Principle: Ceramic material for milling. Standards: ISO 6872:2015 (performance), ISO 7405:2018/ISO 10993 (biocompatibility). Non-sterile, single-use. No energy source or software.

Indications for Use

Indicated for dental restorations, including crowns, bridges, veneers, inlays, and onlays, in patients requiring prosthetic dental work. Processed by dental laboratories or professionals using CAD/CAM or manual milling.

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

• Dental Zirconia Blocks (K192262)

Reference Devices

• X-cera Zirconia Blanks (K153767)

Submission Summary (Full Text)

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February 18, 2022

Shenzhen Yurucheng Dental Materials Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K214005

Trade/Device Name: Zirconia Dental Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 12, 2021 Received: December 21, 2021

Dear Grace Liu:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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) K214005

Device Name Zirconia Dental Ceramics

Indications for Use (Describe)

Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

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)

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# 510(k) Summary - K214005

# 1. Contact Details

#### 1.1 Applicant information

| Applicant Name | Shenzhen Yurucheng Dental Materials Co., Ltd. |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 101-201, Building 4, No.1 Branch of Zhongcheng Life<br>Science Park, No. 14 Zhongxing Road, Xiuxin Community,<br>Kengzi Street Office, Pingshan District, Shenzhen, China |
| Contact person | Fiya Liao |
| Phone No. | [phone] |
| E-mail | [e-mail] |
| Date Prepared | 2022-02-17 |

# 1.2 Submission Correspondent

| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd |
|-------------------------|-------------------------------------------------------|
| | 1713A, 17th Floor, Block A, Zhongguan Times Square, |
| | Nanshan District, Shenzhen, Guangdong Province, China |
| Phone No. | [phone] |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | [e-mail]; [e-mail] |
| Website | http://www.cefda.com |

## 2. Device Information

| Trade name | Zirconia Dental Ceramics |
|---------------------|-----------------------------------|
| Common name | Dental Zirconia Ceramics |
| Classification | II |
| Classification name | Porcelain powder for clinical use |
| Product code | EIH |
| Regulation No. | 21 CFR 872.6660 |

# 3. Legally Marketed Predicate Device

| Trade Name | Dental Zirconia Blocks |
|---------------|------------------------|
| 510(k) Number | K192262 |
| Product Code | EIH |
| Manufacturer | De Corematrix Co.Ltd. |

# 4. Legally Marketed Reference Device

| Trade Name | X-cera Zirconia Blanks |
|---------------|------------------------|
| 510(k) Number | K153767 |
| Product Code | EIH |

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Shenzhen XiangTong Photoelectricity Technology Co., Ltd. Manufacturer |

# 5. Device Description

Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrQz+HfO2+Y2O3 and additional Al2O3 and other oxides. It offers various shapes and dimensions suitable for different milling systems. The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials.

The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.

The proposed device is a single-use device, and provided non-sterile.

#### 6. Intended Use/Indication for Use

Zirconia Dental Ceramics are intended for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

### 7. Substantial Equivalence Comparison

| Comparison<br>item | Proposed Device<br>(K214005) | Predicate Device<br>(K192262) | Reference Device<br>(K153767) | Comment |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Manufacturer | Shenzhen Yurucheng<br>Dental Materials Co., Ltd. | De Corematrix Co.Ltd. | Shenzhen XiangTong<br>Photoelectricity<br>Technology Co., Ltd. | None |
| Product<br>Name | Zirconia Dental Ceramics | Dental Zirconia Blocks | X-cera Zirconia Blanks | None |
| Product Code | EIH | EIH | EIH | Same |
| Regulation<br>Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Class II | Same |
| Prescription<br>Use | Yes | Yes | Yes | Same |
| Indications<br>for Use | Zirconia Dental Ceramics<br>are intended for dental<br>restorations using different<br>CAD/CAM or manual<br>milling machines. All<br>blocks are processed<br>through dental laboratories | Dental Zirconia Blocks are<br>intended for use for the<br>production of artificial<br>teeth in fixed or removable<br>dentures, or for jacket<br>crowns, facing, and<br>veneers. All Blocks are | X-cera Zirconia Blanks are<br>indicated for the<br>production of artificial<br>teeth in fixed or<br>removable dentures, or for<br>jacket crowns, facings,<br>and veneers. | Similar |
| | or by dental professionals. | processed through dental<br>laboratories or by dental<br>professionals. | | |
| Class<br>(per ISO<br>6872:2015) | Type II, Class 5 | Type II, Class 5 | Type II, Class 6<br>(per ISO 6872:2008) | Same |
| Intended<br>User | Professional dental<br>technicians | Professional dental<br>technicians | Professional dental<br>technicians | Same |
| Single Use | Yes | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Shape | Cylinder, Cuboid, U-shape | Blocks, Disc | Cylinder, Disc, Block | Similar to<br>reference<br>device |
| Dimension | Various | Various | Various | Different |
| Color | White | White, Color | White | Similar |
| Composition | ZrO2+HfO2+Y2O3: ≥99%<br>Y2O3: 4.5%~6.0%<br>HfO2: ≤5%<br>Al2O3: ≤0.5%<br>Other oxide: ≤0.5% | White<br>ZrO2+HfO2+Y2O3: ≥99%<br>Y2O3: 4.5%~6.0%<br>HfO2: ≤5%<br>Al2O3: ≤0.5%<br>Other oxide: ≤0.5% | ZrO2: 88%~96%<br>Y2O3: 4%~10%<br>Al2O3: <1%<br>HfO2: <0.05%<br>SiO2: <0.5% | Same |
| Physical<br>Properties | Conform to ISO<br>6872:2015 | Conform to ISO<br>6872:2015 | Conform to ISO<br>6872:2008 | Same |
| Uniformity | Uniform | Uniform | Uniform | Same |
| Freedom<br>from<br>extraneous<br>materials | Free from extraneous<br>materials | Free from extraneous<br>materials | Free from extraneous<br>materials | Same |
| Radioactivity | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | Same |
| Flexural<br>strength | ≥ 800 MPa | > 800 MPa | ≥ 800 MPa | Similar |
| Chemical<br>solubility | < 100 µg/cm² | < 100 µg/cm² | ≤ 100 µg/cm² | Same |
| Linear<br>thermal<br>expansion<br>coefficient | (10.5±0.5)×10-6 K-1 | Not publicly available | (10.5±0.5)×10-6 K-1 | Different |
| Shrinkage<br>factor | 1.253±0.002 | Not publicly available | Shrinkage: 19%~22% | Different |
| Fracture<br>Toughness | ≥ 5.0 MPa*m1/2 | ≥ 5.0 MPa*m1/2 | ≥ 5.0 MPa*m1/2 | Same |

Table 1 Substantial Equivalence Comparison

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Version: A/0

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Shenzhen Yurucheng Dental Materials Co., Ltd.

Product: Zirconia Dental Ceramics

| Biocompatibility | Conform to ISO<br>7405:2018, FDA Guidance | Conform to ISO<br>10993-1:2018,<br>Guidance | ISO FDA | Conform to ISO 7405 and<br>ISO 10993 | Similar |
|------------------|-------------------------------------------|---------------------------------------------|----------------------------------|--------------------------------------|---------|
| Labeling | Complied with 21 CFR<br>part 801 | Complied with 21 CFR<br>part 801 | Complied with 21 CFR<br>part 801 | | Same |

The proposed device has the similar indication for use as the predicate device as well as comparable technical and biocompatibility properties and characteristics, and the minor differences don't raise any additional questions for safety and effectiveness, therefore, the proposed device is substantially equivalent to the predicate device.

### 8. Non-clinical Testing

#### > Performance Testing

The performance tests were performed according to ISO 6872:2015 Dentistry -Ceramic materials, and the test results showed that the proposed device meets the requirements specified in the standard (see Table 2).

| Test Item | Test Results | Judgment |
|-----------------------------------------|--------------------------------|----------|
| Uniformity | Uniform | Pass |
| Freedom from extraneous<br>materials | Free from extraneous materials | Pass |
| Radioactivity | <0.017 Bq.g-1 | Pass |
| Flexural strength | 1076.4 MPa | Pass |
| Linear thermal expansion<br>coefficient | 10.7×10-6K-1 | Pass |
| Chemical solubility | 54.2 µg/cm² | Pass |
| Shrinkage factor | 1.254 | Pass |
| Fracture Toughness | 16.32 MPa*m1/2 | Pass |

## Table 2 Summary of Performance Testing

#### Biocompatibility Testing A

The biocompatibility tests were performed according to ISO 7405:2018 Dentistry -Evaluation of biocompatibility of medical devices used in dentistry (see Table 3), and the test results showed that the proposed device has no biocompatibility issues.

| Biological Endpoint | Reference | Test Result |
|---------------------|------------------|------------------------------------------------------|
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity under the conditions<br>of the study |

| | Table 3 Summary of Biocompatibility Testing | |
|--|---------------------------------------------|--|
|--|---------------------------------------------|--|

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Version: A/0

| | 6.2 of ISO 7405:2018 | No cytotoxicity under the conditions of the study |
|------------------------------|----------------------|-------------------------------------------------------------------|
| | 6.3 of ISO 7405:2018 | No cytotoxicity under the conditions of the study |
| Skin Sensitization | ISO 10993-10:2010 | No skin sensitization under the conditions of the study |
| Oral Mucosa Irritation | ISO 10993-10:2010 | No oral mucosa irritation under the conditions of the study |
| Acute Systemic Toxicity | ISO 10993-11:2017 | No acute systemic toxicity under the conditions of the study |
| Subchronic Systemic Toxicity | ISO 10993-11:2017 | No subchronic systemic toxicity under the conditions of the study |
| Genotoxicity | ISO 10993-3:2014 | No genotoxicity under the conditions of the study |
| Implantation | ISO 10993-6:2016 | No local effects under the conditions of the study |

The results of the non-clinical testing demonstrate that the proposed device is equivalent to the predicate device.

# 9. Clinical Testing

No clinical study is included in this submission.

### 10. Conclusions

The results of comparing the design specifications and non-clinical testing between the proposed device and the legally marketed predicate device (K192262) show that they are Substantially Equivalent (SE).