Dental Zirconia Blocks

K192262 · De Corematrix Co., Ltd. · EIH · May 29, 2020 · Dental

Device Facts

• Record ID: K192262
• Device Name: Dental Zirconia Blocks
• Applicant: De Corematrix Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: May 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

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

Device Story

Dental Zirconia Blocks are zirconia-based ceramic materials used to fabricate dental restorations (crowns, bridges, veneers, inlays). The device is processed by dental laboratories or professionals using CAD/CAM milling systems. The blocks are available in white and pre-colored versions (using inorganic pigments like Fe2O3, Pr2O3, and Er2O3). After milling, the restorations are sintered at 1400-1600°C to achieve final mechanical properties, including high strength, hardness, and fracture toughness. The final output is a custom-fitted ceramic dental prosthesis that matches the patient's natural tooth color. The device is non-sterile and intended for single use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including appearance, dimension, density, flexural strength, linear thermal expansion, chemical solubility, radioactivity, and fracture toughness per ISO 6872:2015/Amd1:2018. Biocompatibility testing was performed per ISO 10993-1:2018, including cytotoxicity, irritation, sensitization, genotoxicity, and systemic toxicity.

Technological Characteristics

Materials: Yttria-stabilized tetragonal zirconia (Y-TZP) conforming to ISO 13356:2015. Composition includes ZrO2, HfO2, Y2O3, Al2O3, and inorganic pigments (Fe2O3, Pr2O3, Er2O3). Form factor: Blocks and discs for CAD/CAM milling. Sintering temperature: 1400-1600°C. Performance: Flexural strength >800 MPa, density ≥6.02 g/cm³ (post-sintering). Non-sterile.

Indications for Use

Indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, 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

• Erran Dental Zirconia (K182068)

Reference Devices

• Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K141724)

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 29, 2020

De Corematrix Co.Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 CHINA

Re: K192262

Trade/Device Name: Dental Zirconia Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 14, 2020 Received: March 2, 2020

Dear Boyle Wang:

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 medical devices and radiation-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) K192262

Device Name Dental Zirconia Blocks

Indications for Use (Describe)

Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and 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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# 510(k) Summary, K192262

This summary of 510(k) substantial equivalence is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

#### 1.0 Submitter's Information

De Corematrix Co.Ltd. Name: Address: No.40 NanBeigang Road, HuKou County, JiuJiang, 332599 JiangXi,China Tel: [phone] Fax: [phone] Contact: Kaixuan Liu Date of Preparation: May.28.2020

#### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

# 2.0 Device Information

Trade name: Dental Zirconia Blocks Powder, Porcelain Common name: Classification name: Porcelain powder for clinical use

# 3.0 Classification

Production code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Panel: Dental

# 4.0 Identification of Predicate Device and Reference Device

Primary Predicate Device:

510(k) Number: K182068 Product Name: Erran Dental Zirconia Manufacturer: Hangzhou Erran Technology Co., Ltd.

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Reference Device:

510(k) Number: K141724 Product Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Liaoning Upcera Company Limited.

#### 5.0 Indication for Use Statement

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

#### 6.0 Device Description

The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance.

They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3).

The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.

The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.

The Dental Zirconia Blocks are provided as non-sterile.

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# 7.0 Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials

ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.

ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-6 Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity

# 8.0 Clinical Test Conclusion

Clinical testing was not required for this submission.

# 9.0 Technological Characteristics and Substantial Equivalence

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

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| Item | Proposed device<br>K192262 | Primary Predicate<br>device K182068 | Reference device<br>K141724 | Remark |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Name | Dental Zirconia Blocks | Erran Dental Zirconia | Upcera Dental Zirconia<br>Blank & Dental Zirconia<br>Pre-Shaded Blank | -- |
| Product Code | EIH | EIH | EIH | Same |
| Regulation No. | 872.6660 | 872.6660 | 872.6660 | Same |
| Class | II | II | II | Same |
| Intended Use | Dental Zirconia Blocks are<br>intended for use for the<br>production of artificial teeth<br>in fixed or removable<br>dentures, or for jacket<br>crowns, facing, and<br>veneers.<br>All Blocks are processed<br>through dental laboratories<br>or by dental professionals. | Erran Dental Zirconia<br>Blocks are indicated for<br>the production of artificial<br>teeth in fixed or<br>removable dentures, or<br>for jacket crowns, facing,<br>and veneers.<br>All Blocks are processed<br>thought dental<br>laboratories or by dental<br>professionals. | Upcera Dental Zirconia<br>Blank & Dental Zirconia<br>Pre-Shaded Blank are<br>used for dental<br>restorations using different<br>CAD/CAM or manual<br>milling machines.All<br>blanks are processed<br>thought dental laboratories<br>or by dental professionals. | Same<br>with the<br>Predicate<br>Device |
| Prescription<br>Use | Yes | Yes | Yes | Same |
| Shapes | Blocks, disc | Blocks, powder | Blocks, disc, and rod. | Same |
| Color | White and Colour | None | None,and pre-shaded | Analysis<br>1 |

#### Table 6-1 General Device Characteristics Comparison Table

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| Chemical<br>Composition<br>(Weight %) | White zirconia: | Zirconia(ZrO2+HfO2+Y2O3<br>≥99.0) | Regular:<br>Zirconia(ZrO2+HfO2+Y2O3+<br>Al2O3≥99.0);<br>Pre-Shaded:<br>Zirconia(ZrO2+HfO2+Y2O3+<br>Al2O3≥98.0)<br>Inorganic pigments: Fe2O3<br>+Pr2O3+Er2O3 <2.0 | Analysis<br>1 | |
|---------------------------------------|-----------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------------------------------|
| | ZrO2+HfO2+Y2O3 | ≥99.0 | | | |
| | Y2O3 | 4.5 ~<br>6.0 | | | |
| | HfO2 | ≤5 | | | |
| | Al2O3 | ≤0.5 | | | |
| | Other oxide | ≤0.5 | | | |
| Colour zirconia: | | | | | |
| | ZrO2+HfO2+Y2O3 | ≥98.0 | | | |
| | Fe2O3 | <0.3 | | | |
| | Pr2O3 | <0.2 | | | |
| | Er2O3 | <1 | | | |
| | Other oxide | ≤0.5 | | | |
| Dimension | Various | | Various | Various | Same |
| Density (pre<br>sintering) | ≥ 3.0 g / cm³ | | 3.10g/cm³ | 2.8~3.2 g/cm³ | Analysis<br>2 |
| Density (post<br>sintering) | ≥ 6.02 g / cm³ | | ≥ 6.02 g / cm³ | ≥ 6.02 g / cm³ | Same |
| Sintering<br>Temperature | 1400-1600 °C | | 1350-1600°C | >1500°C | Analysis<br>3 |
| Flexural<br>strength | > 800MPa | | > 800MPa | ≥900 MPa | Same<br>with the<br>Predicate<br>Device |
| Solubility | <100 µg.cm-2 | | <100µg/ cm² | <100µg/ cm² | Same |

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| Radioactive | uranium-238 active<br>concentration ≤ 1.0 Bq / g. | The activity concentration<br>of U-238is not more than<br>1.0 Bq / g. | Unknown | Same<br>with the<br>Predicate<br>Device |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------|-----------------------------------------|
| Single Use | Yes | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Performance<br>Test | Including:<br>Appearance Test,<br>Dimension Test,<br>Density Test,<br>Product composition<br>Flexural strength,<br>Linear thermal<br>expansion-coefficient<br>Chemical solubility<br>Radioactivity of dental<br>ceramic,<br>Fracture toughness<br>which comply with ISO<br>6872 | Comply with ISO 6872 | Comply with ISO 6872 | Same |
| Biocompatibility | Comply with ISO<br>10993-1:2018, FDA<br>Guidance, tests included<br>cytotoxicity, oral mucosa<br>irritation, skin sensitization. | Comply with ISO<br>10993-1, FDA Guidance | Comply with ISO 10993-1,<br>FDA Guidance | Same |
| | pyrogenicity, acute<br>systemic toxicity, subacute<br>toxicity, subchronic<br>systemic toxicity,<br>implantation effect and<br>genotoxicity etc. | | | |
| Label and<br>Labeling | Conforms to FDA<br>Regulatory Requirements | Conforms to FDA<br>Regulatory Requirements | Conforms to FDA<br>Regulatory Requirements | Same |

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#### Analysis:

The proposed device is highly similar to the predicate device in terms of indications for use, design, material and processing.

The proposed device is different from the predicate device in the following:

- 1) The proposed device has white and colour zirconia blocks. The chemical compositions of white zirconia are same with that of predicate device. The chemical compositions of color zirconia are same with the that of reference device's pre-shaded zirconia blanks. The color is originated from inorganic pigments Fe2O3,Pr2O3 and Er2O3, that are of very small amount(<2.0%). All chemical ingredients in the proposed device have been used in the predicate device and the reference device. Accordingly, it was concluded that the proposed device is substantially equivalent in biocompatibility to the predicate device and the reference device.
- 2) The pre sintering mainly affects the hardness of products which reflects the easy degree of material machining operations. The pre sintering density of the proposed device is a little different with the predicated device and the reference device, but it has no obvious effect on the hardness, this difference does not affect substantial equivalence.
- 3) The sintering temperature is about 1350-1600 ° for the predicated device, while this information is a little different with the proposed device which is about 1400-1600°C. This difference does not affect substantial equivalence as the sintering temperature mainly affects the physical and mechanical property of the dental blocks. Both the proposed and predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.

In summary, the main components of the proposed device and its predicate are substantially equivalent, and the slight differences does not affect the substantial equivalence of the proposed device when compared to the predicate device.

# 10.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the differences between the proposed device and the predicated device are insignificant in terms of substantial equivalence. The proposed device is is substantially equivalent to the predicate device.