(59 days)
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.
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.
This document describes the premarket notification (510(k)) for "Zirconia Dental Ceramics." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove clinical performance or a specific diagnostic accuracy. Therefore, the questions related to AI/ML device performance (e.g., acceptance criteria for accuracy, MRMC studies, ground truth establishment for training/test sets, expert adjudication) are largely not applicable to this type of medical device submission (dental ceramics).
The acceptance criteria and "study" described in this document are focused on non-clinical performance testing to demonstrate that the physical, chemical, and biological properties of the Zirconia Dental Ceramics conform to established standards for dental ceramic materials.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
Acceptance Criteria and Device Performance for Zirconia Dental Ceramics
The acceptance criteria for this device are based on demonstrating compliance with the international standard ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 7405:2018 "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry" for biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ISO 6872:2015, etc.) | Reported Device Performance (Zirconia Dental Ceramics) | Judgment |
|---|---|---|---|
| Uniformity | Uniform (Expected for ceramic materials) | Uniform | Pass |
| Freedom from extraneous materials | Free from extraneous materials (Expected) | Free from extraneous materials | Pass |
| Radioactivity | ≤ 1.0 Bq.g⁻¹ | <0.017 Bq.g⁻¹ | Pass |
| Flexural strength | ≥ 800 MPa | 1076.4 MPa | Pass |
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per predicate/reference) | 10.7 × 10⁻⁶ K⁻¹ | Pass |
| Chemical solubility | < 100 µg/cm² | 54.2 µg/cm² | Pass |
| Shrinkage factor | 1.253 ± 0.002 (as per reference device value) | 1.254 | Pass |
| Fracture Toughness | ≥ 5.0 MPa·m¹/² | 16.32 MPa·m¹/² | Pass |
| Biocompatibility Testing | Acceptance Criteria (ISO 7405:2018, ISO 10993 series) | Reported Test Results | |
| Cytotoxicity (ISO 10993-5:2009, 6.2/6.3 of ISO 7405:2018) | No cytotoxicity | No cytotoxicity under the conditions of the study | Pass |
| Skin Sensitization (ISO 10993-10:2010) | No skin sensitization | No skin sensitization under the conditions of the study | Pass |
| Oral Mucosa Irritation (ISO 10993-10:2010) | No oral mucosa irritation | No oral mucosa irritation under the conditions of the study | Pass |
| Acute Systemic Toxicity (ISO 10993-11:2017) | No acute systemic toxicity | No acute systemic toxicity under the conditions of the study | Pass |
| Subchronic Systemic Toxicity (ISO 10993-11:2017) | No subchronic systemic toxicity | No subchronic systemic toxicity under the conditions of the study | Pass |
| Genotoxicity (ISO 10993-3:2014) | No genotoxicity | No genotoxicity under the conditions of the study | Pass |
| Implantation (ISO 10993-6:2016) | No local effects | No local effects under the conditions of the study | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of test pieces for flexural strength, number of animals for biocompatibility tests). It relies on the methods outlined in the referenced ISO standards.
- Data Provenance: The tests were conducted to demonstrate conformity with international standards (ISO). The location of the testing laboratories or the origin of the data (e.g., country) is not explicitly stated, but the applicant and consultant are based in Shenzhen, China. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is a material science and biocompatibility study, not an AI/ML diagnostic study. The "ground truth" is defined by the physical/chemical/biological properties and the standards they are measured against, not by human expert interpretation of images or clinical outcomes in the context of diagnostic algorithms. The "experts" are the scientists and technicians performing the standardized tests.
4. Adjudication Method for the Test Set
- Not Applicable. There is no human interpretation or subjective assessment that requires adjudication in these physical, chemical, and biological tests. The results are quantitative measurements or qualitative observations (e.g., presence/absence of cytotoxicity) based on standardized protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or software device. Performance is measured against material specifications.
7. The Type of Ground Truth Used
- The "ground truth" for this device is defined by:
- International Standards: Primarily ISO 6872:2015 for physical/chemical properties and ISO 7405:2018 (and related ISO 10993 series) for biocompatibility.
- Material Science Principles: The inherent properties of the zirconia material.
- Laboratory Measurements: Quantitative and qualitative results from standardized test methods.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 LifeScience Park, No. 14 Zhongxing Road, Xiuxin Community,Kengzi Street Office, Pingshan District, Shenzhen, China |
| Contact person | Fiya Liao |
| Phone No. | +86-17727849963 |
| ppk-jidcvcvmr@dingtalk.com | |
| 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. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| 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
| Comparisonitem | Proposed Device(K214005) | Predicate Device(K192262) | Reference Device(K153767) | Comment |
|---|---|---|---|---|
| Manufacturer | Shenzhen YuruchengDental Materials Co., Ltd. | De Corematrix Co.Ltd. | Shenzhen XiangTongPhotoelectricityTechnology Co., Ltd. | None |
| ProductName | Zirconia Dental Ceramics | Dental Zirconia Blocks | X-cera Zirconia Blanks | None |
| Product Code | EIH | EIH | EIH | Same |
| RegulationNumber | 21 CFR § 872.6660 | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Class II | Same |
| PrescriptionUse | Yes | Yes | Yes | Same |
| Indicationsfor Use | Zirconia Dental Ceramicsare intended for dentalrestorations using differentCAD/CAM or manualmilling machines. Allblocks are processedthrough dental laboratories | Dental Zirconia Blocks areintended for use for theproduction of artificialteeth in fixed or removabledentures, or for jacketcrowns, facing, andveneers. All Blocks are | X-cera Zirconia Blanks areindicated for theproduction of artificialteeth in fixed orremovable dentures, or forjacket crowns, facings,and veneers. | Similar |
| or by dental professionals. | processed through dentallaboratories or by dentalprofessionals. | |||
| Class(per ISO6872:2015) | Type II, Class 5 | Type II, Class 5 | Type II, Class 6(per ISO 6872:2008) | Same |
| IntendedUser | Professional dentaltechnicians | Professional dentaltechnicians | Professional dentaltechnicians | 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 toreferencedevice |
| Dimension | Various | Various | Various | Different |
| Color | White | White, Color | White | Similar |
| Composition | ZrO2+HfO2+Y2O3: ≥99%Y2O3: 4.5%~6.0%HfO2: ≤5%Al2O3: ≤0.5%Other oxide: ≤0.5% | WhiteZrO2+HfO2+Y2O3: ≥99%Y2O3: 4.5%~6.0%HfO2: ≤5%Al2O3: ≤0.5%Other oxide: ≤0.5% | ZrO2: 88%~96%Y2O3: 4%~10%Al2O3: <1%HfO2: <0.05%SiO2: <0.5% | Same |
| PhysicalProperties | Conform to ISO6872:2015 | Conform to ISO6872:2015 | Conform to ISO6872:2008 | Same |
| Uniformity | Uniform | Uniform | Uniform | Same |
| Freedomfromextraneousmaterials | Free from extraneousmaterials | Free from extraneousmaterials | Free from extraneousmaterials | Same |
| Radioactivity | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | Same |
| Flexuralstrength | ≥ 800 MPa | > 800 MPa | ≥ 800 MPa | Similar |
| Chemicalsolubility | < 100 µg/cm² | < 100 µg/cm² | ≤ 100 µg/cm² | Same |
| Linearthermalexpansioncoefficient | (10.5±0.5)×10-6 K-1 | Not publicly available | (10.5±0.5)×10-6 K-1 | Different |
| Shrinkagefactor | 1.253±0.002 | Not publicly available | Shrinkage: 19%~22% | Different |
| FractureToughness | ≥ 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 ISO7405:2018, FDA Guidance | Conform to ISO10993-1:2018,Guidance | ISO FDA | Conform to ISO 7405 andISO 10993 | Similar |
|---|---|---|---|---|---|
| Labeling | Complied with 21 CFRpart 801 | Complied with 21 CFRpart 801 | Complied with 21 CFRpart 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 extraneousmaterials | Free from extraneous materials | Pass |
| Radioactivity | <0.017 Bq.g-1 | Pass |
| Flexural strength | 1076.4 MPa | Pass |
| Linear thermal expansioncoefficient | 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 conditionsof 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).
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.