Zirconia Block

K233125 · Hangzhou Ivista Medical Devices Co., Ltd. · EIH · Jan 12, 2024 · Dental

Device Facts

• Record ID: K233125
• Device Name: Zirconia Block
• Applicant: Hangzhou Ivista Medical Devices Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jan 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures,for jacket facing,veneers.All Blocks are processed through dental laboratories or by dental professionals.

Device Story

Zirconia ceramic blocks composed of zirconium oxide; used by dental professionals or laboratories to fabricate dental prostheses (dentures, veneers, jacket facings). Material processed via manual or CAD/CAM milling; requires sintering at 1500±100°C to achieve final density (≥6.00g/cm³). Device is non-sterile, single-use, and intended for permanent restoration. Provides high flexural strength (≥800Mpa) for durable dental applications. Benefits patient by providing biocompatible, high-strength material for restorative dentistry.

Clinical Evidence

No clinical data. Bench testing only. Verification testing included chemical composition, density (pre/post-sintering), sintering shrinkage, thermal expansion, scale-out rate, and appearance. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, acute/subacute/subchronic toxicity, genotoxicity) with all results passing.

Technological Characteristics

Ceramic material (ZrO2, HfO2, Y2O3). Sintering temperature: 1500±100°C. Flexural strength: ≥800Mpa. Density (post-sintering): ≥6.00g/cm³. Non-sterile. Complies with ISO 6872 (dental ceramic standards) and ISO 10993-1:2020 (biocompatibility).

Indications for Use

Indicated for the production of artificial teeth in fixed or removable dentures, jacket facings, and veneers. Intended for use by dental professionals or dental laboratories.

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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 12, 2024

Hangzhou IVISTA Medical Devices Co., Ltd. Yao Cheng General Manager No. 7, Chunjiang Road, Qiaonan Development Zone Ningwei Town, Xiaoshan District Hangzhou, Zhejiang 311217 China

Re: K233125

Trade/Device Name: Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 15, 2023 Received: November 16, 2023

Dear Yao Cheng:

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.

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"

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(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-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 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.

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-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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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) K233125

Device Name Zirconia Block

Indications for Use (Describe)

Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, for jacket facing, veneers. All Blocks are processed through dental laboratories or by dental professionals.

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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# K233125 Section 3 510(k) Summary

#### l 510(k) Submitter

| Device Submitter: | Hangzhou IVISTA Medical Devices Co., Ltd.<br>No. 7, Chunjiang Road, Qiaonan Development Zone, Ningwei Town<br>Xiaoshan District. Hangzhou City 311217, Zhejiang Province, China |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Contact Person: Yao Cheng General Manager Phone: [phone] E-mail: [e-mail]

#### II Device

| Trade Name of Device: | Zirconia Block |
|-----------------------|-------------------|
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Product Code: | EIH |
| Regulatory Class | II |
| Review Panel | Dental |

#### III Predicate Devices

| 510k Number | K192262 |
|-----------------------|------------------------|
| Trade Name of Device: | Dental Zirconia Blocks |
| Regulation Number: | 21 CFR 872.6660 |
| Classification Name: | Powder, Porcelain |
| Regulatory Class | II |
| Product Code: | EIH |

#### IV Device Description

Zirconia ceramic block is made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental appliance/prosthesis (e.g., removable dentures, for jacket facing, veneers) for patient use. It is used to removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

#### V Indications for use

Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures,for jacket facing,veneers.All Blocks are processed through dental laboratories or by dental professionals.

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# VI Technological Characteristics Comparison

| Device<br>Characteristic | Subject Device | Predicate Device<br>(K192262) | Discussion |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Trade name | Zirconia Block | Dental Zirconia Blocks | N/A |
| Regulation Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| Product Code | EIH | EIH | Identical |
| Manufacturer | Hangzhou IVISTA Medical<br>Devices Co., Ltd. | ARUMDENTISTRY Co., Ltd. | N/A |
| Device Classification | Powder, Porcelain | Powder, Porcelain | Identical |
| Intended Use | Zirconia Blocks are intended for<br>use for the production of artificial<br>teeth in fixed or removable<br>dentures,for jacket<br>facing,veneers.All Blocks are<br>processed through dental<br>laboratories or by dental<br>professionals. | Dental Zirconia Blocks are intended<br>for use for the production of artificial<br>teeth in fixed or removable<br>dentures,for jacket facing,veneers.All<br>Blocks are processed through dental<br>laboratories or by dental<br>professionals. | Identical |
| Prescription<br>Use | Yes | Yes | Identical |
| Shapes | Blocks | Blocks, disc | Different<br>Comment 1 |
| Color | White and Colour | White and Colour | same |
| Chemical<br>Composition<br>(Weight %) | ZrO2+HfO2+Y2O3 ≥99.0<br>ZrO2 >90<br>Y2O3 ≤9.5<br>Fe2O3 ≤0.5<br>Er2O3 ≤0.5<br>Other oxide / | White zirconia:<br>ZrO2+HfO2+Y2O3 ≥99.0<br>Y2O3 4.5~6.0<br>HfO2 ≤5<br>Al2O3 ≤0.5<br>Other oxide ≤0.5<br>Color zirconia:<br>ZrO2+HfO2+Y2O3 ≥98.0<br>Fe2O3 <0.3<br>Pr2O3 <0.2<br>Er2O3 <1<br>Other oxide ≤0.5 | Different<br>Comment 2 |
| Density (presintering) | ≥2.75g/cm³ | ≥3.0g/cm³ | Different<br>Comment 3 |
| Density (post<br>sintering) | ≥6.00g/cm³ | ≥6.02g/cm³ | |
| Device<br>Characteristic | Subject Device | Predicate Device<br>(K192262) | Discussion |
| Sintering<br>Temperature | $1500\pm100$ °C | 1400-1600 °C | Identical |
| Flexura<br>strength | ≥800Mpa | >800Mpa | Identical |
| Solubilit | ≤100µg/cm² | <100µg/cm² | Identical |
| Radioactive | ≤ 1.0 Bq / g | uranium-238concentration ≤ 1.0 Bq / g. | Identical |
| Single Use | Yes | Yes | Identical |
| Sterile | Non-sterile | Non-sterile | Identical |
| Performance<br>Test | Including:Appearance<br>Test,Dimension Test,Density<br>Test,Product composition<br>Flexural strength,Linear thermal<br>expansion-coefficient,Chemical<br>solubility Radioactivity of dental<br>of ceramic,<br>thermal<br>Fracture toughness comply with<br>ISO 6872 | Including:Appearance<br>Test,Dimension Test,Density<br>Test,Product composition Flexural<br>strength,Linear thermal<br>expansion-coefficient,Chemical<br>solubility Radioactivity of dental of<br>ceramic,<br>thermal<br>Fracture toughness comply with ISO<br>6872 | Identical |
| Biocompatibility | Comply ISO10993-1:2020 | Comply ISO10993-1:2018<br>FDA Guidance, tests included<br>cytotoxicity, oral mucosa irritation,<br>skin sensitization,<br>pyrogenicity,acute systemic toxicity,<br>subacute toxicity,subchronic<br>systemic toxicity,implantation effect<br>and genotoxicity etc | Different<br>Comment 4 |

VI-1: Comparison of Zirconia Block

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### Comment 1

Shapes in the subject device have been used in the predicate deviceThe form of the product is not the same but the composition and intended use are the same. Accordingly, it was concluded that the proposed device is substantially equivalent to the predicate device.

## Comment 2

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All chemical ingredients in the proposed device have been used in thepredicate device and the reference device. Accordingly, it was concludedthat the proposed device is substantially equivalent in biocompatibility tothe predicate device and the reference device.

#### Comment 3

The pre sintering mainly affects the hardness of products which reflects theeasy degree of material machining operations. The pre sintering density ofthe proposed device is a little different with the predicated device and thereference device, but it has no obvious effect on the hardness, thisdifference does not affect substantial equivalence.

#### Comment 4

ISO10993-1:2018 Updated to ISO10993-1:2020, we do biocompatibility according to the latest standard and meet the requirements.

#### VII Summary of Non-clinical Testing (Bench)

The non-clinical testing for Zirconia Block was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.

| ID# | Test | Method | Acceptance<br>Criteria | Conclusion |
|--------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Physical Testing of Dental Glass Ceramics | | | Test results of ten samples |
| 1.1 | Chemical<br>Composition | Y2O3+Zr(Hf)O2>99.5% | | 99.9%,99.9%,99.9%,99.9%,99.9%,<br>99.9%,99.9%,99.9%,99.9%,99.9% |
| 1.2 | Chemical<br>Composition | Y2O3+Zr(Hf)O2>99.5% | | 912Mpa, 914Mpa, 910Mpa, 912Mpa,<br>915Mpa, 916Mpa, 906Mpa, 913Mpa,<br>913Mpa, 916Mpa |
| 1.3 | Pre-sintering | ≥2.75g/cm³ | Product<br>technical<br>requirements | 3.1 and 6.07g/cm³, 3.1 and 6.06g/<br>cm³, 3.1 and 6.06g/cm³, 3.1 and<br>6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and<br>6.07g/cm³, 3.1 and 6.06g/cm³, 3.11<br>and 6.07g/cm³, 3.1 and 6.06g/cm³,<br>3.12 and 6.06g/cm³ |
| 1.3 | Post-sintering | ≥6.00g/cm³ | | 6.07g/cm³, 3.1 and 6.06g/cm³, 3.1 and<br>6.07g/cm3, 3.1 and 6.06g/cm3, 3.11<br>and 6.07g/cm³, 3.1 and 6.06g/cm³ |
| 1.4 | Sintering<br>Shrinkage Rate | 19%-22% | | 20.53%, 20.51%, 20.49%,20.51%,<br>20.46%, 20.55%, 20.55%,20.51%,<br>20.5%, 20.51% |
| 1.5 | Pre-sintering | ≤2000µg/cm² | 0 and 0µg/cm², 0 and 0µg/cm², 0 and0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm² | |
| 1.5 | Post-sintering | ≤100µg/cm² | 0 and 0µg/cm², 0 and 0µg/cm², 0 and0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm², 0 and 0µg/cm² | |
| 1.6 | Linear thermal<br>expansion-coeffici<br>ent | $(10.5±0.5) × 10-6 K-1$ | 10.5×10-6 K-1, 10.6 ×10-6 K-1<br>10.3×10-6 K-1, 10.4 ×10-6 K-1<br>10.6×10-6 K-1, 10.3 ×10-6 K-1<br>10.5×10-6 K-1, 10.4 ×10-6 K-1<br>10.4×10-6 K-1,10.5×10-6 K-1 | |
| 1.7 | Scale out rate | The scaling factor falls within<br>the range in between 1.210<br>and 1.260, and the deviation<br>of the actural value from the<br>nominal value should not be<br>greater than 0.005. | 1.245, 1.250, 1.240, 1.242, 1.240,<br>1.246, 1.240, 1.248, 1.238, 1.249 | |
| 1.8 | Scale out rate | The scaling factor falls within<br>the range in between 1.210<br>and 1.260, and the deviation<br>of the actural value from the<br>nominal value should not be<br>greater than 0.005. | 1.245, 1.250, 1.240, 1.242, 1.240,<br>1.246, 1.240, 1.248, 1.238, 1.249 | |
| 1.9 | Appearance | Surface: surface should be<br>smooth and pore- free. | Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes,<br>Yes, Yes, Yes | |
| | | The color of zirconia<br>porcelain block used for<br>chip processing (initial<br>sintering state) should be<br>uniform, there should be no<br>local pigment separation<br>phenomenon, there should<br>be no foreign body<br>attached. | Yes, Yes, Yes, Yes, Yes, Yes, Yes, Yes,<br>Yes, Yes, Yes | |
| | | Size: the size error<br>should be less than ±<br>0.2mm. | +0.03mm, +0.03mm, +0.03mm,<br>+0.02mm, +0.02mm, +0.03mm,<br>+0.02mm, +0.02mm, +0.02mm, | |
| 1.10 | Packaging | The packing identification<br>should be distinct, and the<br>packing material should not<br>have obvious changes. | No obvious changes, no obvious<br>changes, no obvious changes, no<br>obvious changes, no obvious changes,<br>no obvious changes, no obvious<br>changes, no obvious changes, no<br>obvious changes, no obvious changes | |
| Biocompatibility Testing | | | | |
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-Cytotoxicity | Pass |
| 2.2 | Sensitization | ISO 10993-10:2021 | Non-Sensitization | Pass |
| 2.3 | Irritation or<br>intracutaneous<br>reactivity | ISO 10993-23:2021 | Non-Irritation or<br>intracutaneous<br>reactivity | Pass |
| 2.4 | Acute system<br>ictoxicity | ISO 10993-11:2017 | Non-Acute system<br>ictoxicity | Pass |
| 2.5 | Subacute toxicity | ISO 10993-11:2017 | Non-Subacute<br>toxicity | Pass |
| 2.6 | Sub chronic<br>toxicity | ISO 10993-11:2017 | Non-Sub chronic<br>toxicity | Pass |
| 2.7 | Genotoxicity | ISO 10993-3:2014 | Non-Genotoxicity | Pass |

#### Table VII-1: Performance testing was conducted on the subject device

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## VIII Clinical Test Conclusion

No clinical study is included in this submission.

#### IX Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Zirconia Block is as safe as effective, and performs as well as or better than the legally marketed device.

#### X Copy Statement

The Copy is an exact duplicate of the paper copy.

Signature of the applicant:

花遥

date of the submission:2023.12.11