(59 days)
Not Found
No
The summary describes a dental zirconia block used for manufacturing restorations via CAD/CAM or manual milling. There is no mention of AI or ML in the intended use, device description, or performance studies. The process relies on traditional CAD/CAM or manual methods, not AI/ML for design or manufacturing.
No.
This device is a material (zirconia block) used for manufacturing dental restorations, not a therapeutic device itself. Its function is to be processed into crowns, bridges, and other restorations, which then serve a restorative purpose.
No
The device is a dental material (zirconia block) used for manufacturing dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it is a "Dental Zirconia Pre-shaded Block," which is a physical material used in the manufacturing of dental restorations. It is processed using CAD/CAM or manual milling, indicating a hardware component (milling machine) is required for its use. The document focuses on the material properties and performance according to ISO 6872, not on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manufacturing of dental restorations (crowns, bridges, veneers, etc.) for the patient's teeth. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a material (zirconia block) that is processed into a final dental product. It does not analyze biological samples or provide information about a patient's health status.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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). Key results:
- Uniformity: Uniform (Pass)
- Freedom from extraneous materials: Free from extraneous materials (Pass)
- Radioactivity: 0.019 Bq·g-1 (Pass)
- Flexural strength: Multilayer-3D: 1172.2 MPa, Color, Multilayer-SHT: 1110.9 MPa (Pass)
- Linear thermal expansion coefficient: Multilayer-3D: 10.8 x 10^-6 K-1, Color, Multilayer-SHT: 10.9 x 10^-6 K-1 (Pass)
- Chemical solubility: Multilayer-3D: 53.4 µg/cm², Color, Multilayer-SHT: 52.6 µg/cm² (Pass)
- Shrinkage factor: Multilayer-3D: 1.255, Color, Multilayer-SHT: 1.259 (Pass)
- Fracture Toughness: Multilayer-3D: 18.24 MPam^1/2, Color, Multilayer-SHT: 17.88 MPam^1/2 (Pass)
Biocompatibility Testing: 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. Key results:
- Cytotoxicity (ISO 10993-5:2009, 6.2 of ISO 7405:2018, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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. | +86-17727849963 |
| ppk-jidcvcvmr@dingtalk.com | |
| 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. | +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 | 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.
4
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
| item | Proposed Device (K214003) | Predicate Device (K183304) | Comment |
|---|---|---|---|
| Manufacturer | Shenzhen Yurucheng Dental | ||
| Materials Co., Ltd. | ZIRKONZAHN SRL | None | |
| Product Name | Dental Zirconia Pre-shaded Block | PRETTAU®, ICE and Z-WHITE | |
| zirconia blanks | None | ||
| Product Code | EIH | EIH | Same |
| Regulation | |||
| Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| Prescription | |||
| Use | Yes | Yes | Same |
| Indications for | |||
| Use | 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, 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. | Prettau®, Prettau® 2, Prettau® 2 | ||
| Coloured, Prettau® 2 Dispersive, | |||
| ICE Translucent, ICE Premium, | |||
| ICE Abutment, ICE Translucent | |||
| Plus, ICE Translucent Plus | |||
| Coloured, ICE Translucent Plus | |||
| Dispersive and Z-White are | |||
| intended for the manufacturing of | |||
| metal-free 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. | |||
| Prettau® 3, Prettau® 3 Coloured, | |||
| Prettau® 3 Dispersive, Prettau® 4 | |||
| Anterior®, Prettau® 4 Anterior® | |||
| Coloured and Prettau® 4 | |||
| Anterior® Dispersive are destined | |||
| for the manufacturing of | |||
| metal-free 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 have to be categorized | |||
| as class 4 according to ISO 6872. | |||
| The products have been | |||
| developed for use with Colour | |||
| Liquid, ICE Zirkon Ceramics, ICE | |||
| Zirkon Stains and ICE Zirkon | Similar | ||
| instructions of use when using | |||
| these products. The blocks are | |||
| suitable for all milling units, which | |||
| are able to process presintered | |||
| zirconia and which have the | |||
| proper clamping device for the | |||
| corresponding block. | |||
| Class | |||
| (per ISO | |||
| 6872:2015) | Class 4 | ||
| Multilayer-3D | |||
| Class 5 | |||
| Color, Multilayer-SHT | Class 4 | ||
| Prettau® 3, Prettau® 4 Anterior | |||
| Class 5 | |||
| Prettau®, Prettau® 2, ICE group, | |||
| 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 | |||
| Properties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom from | |||
| extraneous | |||
| materials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | Same |
| Flexural | |||
| strength | Multilayer-3D: | ||
| ≥ 500 MPa | |||
| Color, Multilayer-SHT: | |||
| ≥ 800 MPa | Prettau® 3, Prettau® 4 Anterior: | ||
| 600 MPa | |||
| Prettau®, Prettau® 2, ICE group, | |||
| Z-White: | |||
| ≥ 900 MPa | Similar | ||
| Chemical | |||
| solubility | 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 Results | |||
|---|---|---|---|
| Test Item | Multilayer-3D | Color, Multilayer-SHT | Judgment |
| Uniformity | Uniform | Uniform | Pass |
| Freedom from | |||
| extraneous materials | Free from extraneous | ||
| materials | Free from extraneous | ||
| materials | Pass | ||
| Radioactivity | $0.019$ Bq·g-1 | $0.019$ Bq·g-1 | Pass |
| Flexural strength | 1172.2 MPa | 1110.9 MPa | Pass |
| Linear thermal | |||
| expansion coefficient | $10.8 \times 10^{-6}$ K-1 | $10.9 \times 10^{-6}$ K-1 | Pass |
| Chemical solubility | 53.4 µg/cm² | 52.6 µg/cm² | Pass |
| Shrinkage factor | 1.255 | 1.259 | Pass |
| Fracture Toughness | 18.24 MPa*m1/2 | 17.88 MPa*m1/2 | Pass |
| Table 2 Summary of Performance Testing | ||
|---|---|---|
| ---------------------------------------- | -- | -- |
> Biocompatibility Testing
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.
Table 3 Summary of Biocompatibility Testing
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Version: A/0
| Biological Endpoint | Reference | Test Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity under the conditions |
| of the study | ||
| Cytotoxicity | 6.2 of ISO 7405:2018 | No cytotoxicity under the conditions |
| of the study | ||
| Cytotoxicity | 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.
8. Clinical Testing
No clinical study is included in this submission.
9. Conclusions
The results of comparing the design specifications and non-clinical testing between the proposed device and the legally marketed predicate device (K183304) show that they are Substantially Equivalent (SE).