Dental Zirconia Pre-shaded Block

K214003 · Shenzhen Yurucheng Dental Materials Co., Ltd. · EIH · Feb 18, 2022 · Dental

Device Facts

• Record ID: K214003
• Device Name: Dental Zirconia Pre-shaded Block
• 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

Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872. Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872. The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

Device Story

Dental Zirconia Pre-shaded Block consists of yttria-stabilized zirconia with inorganic pigments (Fe2O3, Er2O3, Mn2O3) for tooth-matching color. Device provided as presintered blocks in various shapes/dimensions. Professional dental technicians use CAD/CAM or manual milling machines to process blocks into dental restorations (crowns, bridges, veneers, inlays, onlays). After milling, restorations are sintered in dental labs to achieve final hardness and color. Device enables creation of patient-specific, metal-free dental prosthetics. Benefits include restoration of tooth function and aesthetics. Used in dental laboratory settings.

Clinical Evidence

No clinical data. Bench testing only. Performance testing per ISO 6872:2015 confirmed uniformity, radioactivity (0.019 Bq/g), flexural strength (1110.9–1172.2 MPa), chemical solubility (52.6–53.4 µg/cm²), and fracture toughness (17.88–18.24 MPa*m1/2). Biocompatibility testing per ISO 7405:2018 and ISO 10993 series confirmed no cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, or adverse implantation effects.

Technological Characteristics

Material: Yttria-stabilized zirconia (ZrO2, HfO2, Y2O3, Al2O3) with inorganic pigments. Form factor: Presintered blocks for CAD/CAM or manual milling. Energy source: None (mechanical processing). Connectivity: None. Sterilization: Non-sterile. Standards: ISO 6872:2015 (ceramic materials), ISO 7405:2018 (biocompatibility).

Indications for Use

Indicated for dental patients requiring partial/single crowns, full arch occlusally screwed bridges, inlays, onlays, veneers, full contour restorations, or reduced structures for veneering. Multilayer-3D also indicated for implant superstructures for 3-unit restorations in anterior/posterior regions. For use by professional dental technicians.

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

• PRETTAU®, ICE and Z-WHITE zirconia blanks (K183304)

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: K214003

Trade/Device Name: Dental Zirconia Pre-shaded Block 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.

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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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K214003

Device Name Dental Zirconia Pre-shaded Block

#### Indications for Use (Describe)

Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.

Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior tooth region. The products are categorized into class 4 according to ISO 6872.

The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

| 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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Version: A/0

# 510(k) Summary - K214003

#### 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 Science Park, No. 14 Zhongxing Road, Xiuxin Community, 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 | |

| | 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 | Dental Zirconia Pre-shaded Block |
|---------------------|-----------------------------------|
| 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 | PRETTAU®, ICE and Z-WHITE zirconia blanks |
|---------------|-------------------------------------------|
| 510(k) Number | K183304 |
| Product Code | EIH |
| Manufacturer | ZIRKONZAHN SRL |

#### 4. Device Description

Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.

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Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it offers various shapes and dimensions suitable for different milling systems.

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 performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.

#### 5. Intended Use/Indication for Use

Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.

Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872.

The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

# 6. Substantial Equivalence Comparison

| Comparison<br>item | Proposed Device (K214003) | Predicate Device (K183304) | Comment |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Shenzhen Yurucheng Dental<br>Materials Co., Ltd. | ZIRKONZAHN SRL | None |
| Product Name | Dental Zirconia Pre-shaded Block | PRETTAU®, ICE and Z-WHITE<br>zirconia blanks | None |
| Product Code | EIH | EIH | Same |
| Regulation<br>Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| Prescription<br>Use | Yes | Yes | Same |
| Indications for<br>Use | Color and Multilayer-SHT are<br>intended for the manufacturing of<br>partial and single crowns, full<br>arch occlusally screwed bridges,<br>inlays, onlays, and veneers, full<br>contour restorations as well as<br>reduced structures in<br>combination with veneering<br>ceramics. The products are<br>categorized into class 5<br>according to ISO 6872.<br>Multilayer-3D is intended for the<br>manufacturing of partial and<br>single crowns, max. 3-unit<br>bridges, inlays, onlays and<br>veneers, full contour restorations<br>as well as for reduced structures<br>in combination with veneering<br>ceramics and implant<br>superstructures for 3-unit<br>restorations in the anterior and<br>posterior tooth region. The<br>products are categorized into<br>class 4 according to ISO 6872.<br>The products are suitable for all<br>milling machines which are able<br>to process presintered zirconia<br>and which have the proper<br>clamping device for the<br>corresponding block. | Prettau®, Prettau® 2, Prettau® 2<br>Coloured, Prettau® 2 Dispersive,<br>ICE Translucent, ICE Premium,<br>ICE Abutment, ICE Translucent<br>Plus, ICE Translucent Plus<br>Coloured, ICE Translucent Plus<br>Dispersive and Z-White are<br>intended for the manufacturing of<br>metal-free partial and single<br>crowns, full arch occlusally<br>screwed bridges, inlays, onlays,<br>and veneers, full contour<br>restorations as well as reduced<br>structures in combination with<br>veneering ceramics. The<br>products are categorized into<br>class 5 according to ISO 6872.<br>Prettau® 3, Prettau® 3 Coloured,<br>Prettau® 3 Dispersive, Prettau® 4<br>Anterior®, Prettau® 4 Anterior®<br>Coloured and Prettau® 4<br>Anterior® Dispersive are destined<br>for the manufacturing of<br>metal-free partial and single<br>crowns, max. 3-unit bridges,<br>inlays, onlays and veneers, full<br>contour restorations as well as for<br>reduced structures in<br>combination with veneering<br>ceramics and implant<br>superstructures for 3-unit<br>restorations in the anterior and<br>posterior tooth region. The<br>products have to be categorized<br>as class 4 according to ISO 6872.<br>The products have been<br>developed for use with Colour<br>Liquid, ICE Zirkon Ceramics, ICE<br>Zirkon Stains and ICE Zirkon | Similar |
| | | instructions of use when using<br>these products. The blocks are<br>suitable for all milling units, which<br>are able to process presintered<br>zirconia and which have the<br>proper clamping device for the<br>corresponding block. | |
| Class<br>(per ISO<br>6872:2015) | Class 4<br>Multilayer-3D<br>Class 5<br>Color, Multilayer-SHT | Class 4<br>Prettau® 3, Prettau® 4 Anterior<br>Class 5<br>Prettau®, Prettau® 2, ICE group,<br>Z-White | Same |
| Composition | Based on yttria-stabilized zirconia | Based on yttria-stabilized zirconia | Similar |
| Color | Color | White, Color | Similar |
| Intended User | Professional dental technicians | Professional dental technicians | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Physical<br>Properties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom from<br>extraneous<br>materials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | Same |
| Flexural<br>strength | Multilayer-3D:<br>≥ 500 MPa<br>Color, Multilayer-SHT:<br>≥ 800 MPa | Prettau® 3, Prettau® 4 Anterior:<br>600 MPa<br>Prettau®, Prettau® 2, ICE group,<br>Z-White:<br>≥ 900 MPa | Similar |
| Chemical<br>solubility | < 100 µg/cm² | < 100 µg/cm² | Same |
| Linear thermal<br>expansion<br>coefficient | $(10.5±0.5)×10-6 K-1$ | Not publicly available | Different |
| Shrinkage<br>factor | 1.257±0.002 | Not publicly available | Different |
| Fracture | Multilayer-3D: | Not publicly available | Different |
| Toughness | $≥ 3.5 MPa*m1/2$ | | |
| | Color, Multilayer-SHT:<br>$≥ 5.0 MPa*m1/2$ | | |
| Biocompatibility | Conform to ISO 7405:2018 | Conform to ISO 10993-1 | Similar |
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |

Table 1 Substantial Equivalence Comparison

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Version: A/0

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Version: A/0

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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 do…