Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)

K240672 · Zhejiang Zahndent Biotechnology Co., Ltd. · EIH · Jun 7, 2024 · Dental

Device Facts

• Record ID: K240672
• Device Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
• Applicant: Zhejiang Zahndent Biotechnology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jun 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Device Story

Device consists of zirconia powder blanks (ZrO2, Y2O3, HfO2, Al2O3) used for dental restorations; pre-shaded versions include inorganic pigments (Fe2O3, Er2O3, MnO). Blanks are milled by dental professionals or laboratories using CAD/CAM or manual systems to create crowns, bridges, veneers, and inlays/onlays. Final shapes are sintered at 1450°C to achieve required mechanical properties. Output is a custom-fitted ceramic dental prosthesis. Device benefits include restoration of tooth function and aesthetics. No software or electronic components involved.

Clinical Evidence

No clinical data. Bench testing performed per ISO 6872:2015 (flexural strength, chemical solubility, density, fracture toughness). Biocompatibility testing performed per ISO 10993 series (cytotoxicity, oral mucosa irritation, skin sensitization, systemic toxicity, genotoxicity, and muscle implantation) with all results passing.

Technological Characteristics

Materials: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3 ≥99.0%) conforming to ISO 13356. Pre-shaded versions include inorganic pigments (<2.0%). Form factor: Blocks, discs, and rods. Sintering temperature: 1450°C. Performance conforms to ISO 6872. No software, electronics, or connectivity.

Indications for Use

Indicated for dental restorations (crowns, bridges, veneers, inlay/onlay) in patients requiring prosthetic dental devices, 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

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

Submission Summary (Full Text)

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June 7, 2024

Zhejiang Zahndent Biotechnology Co., Ltd % Shangfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road Science Town, Huangpu District Guangzhou City, Guangdong 510663 China

Re: K240672

Trade/Device Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 11, 2024 Received: March 11, 2024

Dear Shangfeng Jiang:

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.

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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 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 QS 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

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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

Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K240672

Device Name

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (ZD-HT-PLUS, ZD-ST, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)

Indications for Use (Describe)

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Type of Use (Select one or both, as applicable)

1XPrescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K240672

#### Date of Summary Preparation: February 20, 2024

#### 1. Submitter's Identifications

Submitter's Name: Zhejiang Zahndent Biotechnology Co.,Ltd Address: #203,Building 8,Lecheng Industrial Park, Xingian, HuangYan District, 318020 Taizhou, Zhejiang Province, China Zip Code: 318020 Contact Person: Yaping Huang Contact Title: General Manager Contact E-mail Address: Claire(@zahndent.com Tel: [phone]

#### 2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: [e-mail] Tel: [phone] Fax: [phone]

### 3. Name of the Device

Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Model: ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML. Regulation Medical Specialty: Dental Review Panel: Dental Product Code: EIH Regulation Number: 21 CFR 872.6660 Device Classification: Class II

### 4. The Predicate Devices

Predicate device: K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Liaoning Upcera Company Limited

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# 5. Device Description

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery – Ceramic materials based on vttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

# 6. Intended Use of Device

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

### 7. Summary of Substantial Equivalence

| | Proposed Device | Predicate device | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510k Number | | K141724 | ------ |
| Product Code | EIH | EIH | Same |
| Proprietary Name | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | ------ |
| Model: | ZD-HT-PLUS,<br>ZD-ST, ZD-SHT,<br>ZD-HT-C, ZD-ST-C,<br>ZD-SHT-C,<br>ZD-UT-C,<br>ZD-ST-ML,<br>ZD-SHT-ML,<br>ZD-UT-ML,<br>ZD-3D-Pro-ML | ------ | ------ |
| | ZD-4D-Pro-ML. | | |
| Manufacturer | Zhejiang Zahndent<br>Biotechnology<br>Co.,Ltd | Liaoning Upcera<br>Company Limited | ----- |
| Indications for<br>Use | Dental Zirconia<br>Blank & Dental<br>Zirconia<br>Pre-Shaded Blank<br>are used for dental<br>restorations using<br>different<br>CAD/CAM or<br>manual milling<br>machines. All<br>blanks are<br>processed through<br>dental laboratories<br>or by dental<br>professionals. | Upcera Dental<br>Zirconia Blank &<br>Dental Zirconia<br>Pre-Shaded Blank<br>are used for dental<br>restorations using<br>different<br>CAD/CAM or<br>manual milling<br>machines. All<br>blanks are<br>processed though<br>dental laboratories<br>or by dental<br>professionals. | Same |
| Basic design | Blocks, and rods | Blocks, disc, and<br>rod | Same |
| Materials | Regular:<br>Zirconia (ZrO2+<br>Y2O3+ HfO2+<br>$Al2O3≥99.0%$ )<br><br>Pre-shaded:<br>Zirconia (ZrO2+<br>Y2O3+ HfO2+<br>$Al2O3≥99.0%$ )<br><br>Inorganic pigments<br>(Fe2O3, Er2O3 and<br>MnO <2.0%) | Regular:<br>Zirconia (ZrO2+<br>Y2O3+ HfO2+<br>$Al2O3≥99.0%$ )<br><br>Pre-Shaded:<br>Zirconia (ZrO2+<br>Y2O3+ HfO2+<br>$Al2O3≥98.0%$ )<br><br>Inorganic pigments<br>(Fe2O3, Pr2O3, and<br>Er2O3 <2.0%) | Similar¹ |
| Processing | Sintering at<br>temperature:<br>1450°C | Sintering at<br>temperature:<br>1500°C | Similar² |
| Dimension | Various | Various | Same |
| Single Use | Yes | Yes | Same |
| Color | None, and<br>Pre-shaded (for<br>pre-shaded series) | None, and<br>Pre-shaded (for<br>pre-shaded series) | Same |

### Table 1 Comparison to Predicate Device

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The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices. The minor differences are that as below:

Note 1: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) of proposed device which is not less than 99.0% is higher than that of the predicate device. The three inorganic pigments of the proposed device contain Fe203, Er2O3 and MnO, while those of the predicate device are Fe2O3, Pr2O3, and Er2O3. These are minor differences and the biocompatibility testing of the overall proposed device passed.

Note 2: Processing (Sintering at temperature) of the proposed device is slightly lower 5°C than that of the predicate device. This is minor difference and the performance testing of the proposed device passed.

### 8. Summary of Non-Clinical Testing

Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Zirconia Blank met its specifications. All tests were verified to meet acceptance criteria. Test results on radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, shrinkage factor, pre-sintered density, sintered density, and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.

According to ISO 10993-1:2018 and ISO7405:2018, we evaluated and conducted the compatibility test for the proposed device. The following table shows the biocompatibility testing results.

| Item | Proposed device | Result |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity<br>(ISO 10993-5:2009) | Under the conditions of this study, the test article<br>was non cytotoxic for 2 h and 24 h in the filter<br>diffusion method.<br><br>Under the conditions of this study, the test article<br>was accepted in the agar diffusion method.<br><br>Under the conditions of this study, the test article<br>has no potential toxicity to L-929 cells. | Pass |
| Oral Mucosa Irritation<br>(ISO 10993-23:2021) | The test article has no potential oral mucosa<br>irritation in the Syrian hamsters. | Pass |
| Skin Sensitization<br>Test<br>(ISO 10993-10:2021) | The test article showed no evidence of causing<br>delayed dermal contact sensitization in the guinea<br>pig. | Pass |
| Subacute Toxicity<br>Test | The test result showed that the test article did not<br>induce subacute systemic toxicity in rats under | Pass |

Table 2 Biocompatibility testing

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# Zhejiang Zahndent Biotechnology Co.,Ltd

| (ISO 10993-11:2017) | this condition . | |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Subacute Systemic<br>Toxicity Test<br>(ISO 10993-11:2017) | The test result showed that the test article did not<br>induce subacute systemic toxicity in rats under<br>this condition. | Pass |
| Acute Systemic<br>Toxicity<br>(ISO 10993-11:2017) | The test article showed no evidence of causing<br>acute system toxicity in the ICR mice. | Pass |
| In Vitro Mammalian<br>Cell Gene Mutation<br>Test<br>(ISO 10993-3:2014) | Under the conditions of this study, the test article<br>is considered non-mutagenic. | Pass |
| In vitro Mammalian<br>Chromosome<br>Aberration Test<br>(ISO 10993-3:2014) | Under the conditions of this study, the test article<br>did not induce structural chromosome aberrations<br>in cultured CHL cells. | Pass |
| Bacterial Reverse<br>Mutation Test<br>(ISO 10993-3:2014) | Under the conditions of this study, the number of<br>reverting colonies in the test article group is not<br>equal to or greater than 2 times that of the<br>spontaneous control, so the test article have no<br>potential mutagenesis. | Pass |
| Muscle Implant<br>(ISO 10993-6:2016) | The test result showed that the test article did not<br>induce local effects after implantation of<br>biomaterials in rabbits under this condition. | Pass |

Note: Testing were Performed on Dental Zirconia Blank ST with Pre-Shaded powder C4 (C4 is deep color, see the VITA 16 color shade guide picture) to cover the regular and pre-shaded zirconia blanks.

### 9. Clinical Test Conclusion

No clinical study is included in this submission.

### 10. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that subject device Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank performs as well as or better than the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is substantial equivalent to the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank.