(59 days)
No
The summary describes a material (zirconia) used for dental restorations and its physical properties, not a software or algorithm that would typically incorporate AI/ML. The use of CAD/CAM is mentioned, but this is a standard digital manufacturing process, not necessarily indicative of AI/ML. There are no mentions of AI, DNN, ML, image processing, training sets, or performance metrics related to algorithmic performance.
No.
The device is a material used to create dental restorations, not a therapeutic device that treats or prevents disease.
No
Explanation: The device is described as a material for fabricating dental restorations (crowns, bridges, etc.) and is used for treatment, not for diagnosing a condition or disease.
No
The device description clearly states it is composed of yttria-stabilized zirconia and other oxides, and is processed into physical dental restorations. This indicates it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (crowns, bridges, etc.) for patients. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material (zirconia) used to fabricate a medical device (dental restoration). It's not designed to analyze samples from the human body to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological substance or condition for the purpose of diagnosis, monitoring, or prognosis.
- Performance Studies: The performance studies focus on the material properties and biocompatibility of the zirconia, which are relevant to its use as a dental restorative material, not as a diagnostic tool.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. This device is used in vivo (in the body) as a component of a dental restoration.
N/A
Intended Use / Indications 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.
Product codes
EIH
Device Description
Zirconia Dental Ceramics is composed of yttria-stabilized zirconia. It contains ZrO2+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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories or by dental professionals.
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.
Key results:
Uniformity: Uniform, Pass
Freedom from extraneous materials: Free from extraneous materials, Pass
Radioactivity:
§ 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.
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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
1
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 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
| 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 |
4
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
| Comparison
item | Proposed Device
(K214005) | Predicate Device
(K192262) | Reference Device
(K153767) | Comment |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Manufacturer | Shenzhen Yurucheng
Dental Materials Co., Ltd. | De Corematrix Co.Ltd. | Shenzhen XiangTong
Photoelectricity
Technology Co., Ltd. | None |
| Product
Name | Zirconia Dental Ceramics | Dental Zirconia Blocks | X-cera Zirconia Blanks | None |
| Product Code | EIH | EIH | EIH | Same |
| Regulation
Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Class II | Same |
| Prescription
Use | Yes | Yes | Yes | Same |
| Indications
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 | 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 | X-cera Zirconia Blanks are
indicated for the
production of artificial
teeth in fixed or
removable dentures, or for
jacket crowns, facings,
and veneers. | Similar |
| | or by dental professionals. | processed through dental
laboratories or by dental
professionals. | | |
| Class
(per ISO
6872:2015) | Type II, Class 5 | Type II, Class 5 | Type II, Class 6
(per ISO 6872:2008) | Same |
| Intended
User | Professional dental
technicians | Professional dental
technicians | Professional dental
technicians | 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 to
reference
device |
| 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% | White
ZrO2+HfO2+Y2O3: ≥99%
Y2O3: 4.5%~6.0%
HfO2: ≤5%
Al2O3: ≤0.5%
Other oxide: ≤0.5% | ZrO2: 88%~96%
Y2O3: 4%~10%
Al2O3: 800 MPa | ≥ 800 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 Item | Test Results | Judgment |
|---|---|---|
| Uniformity | Uniform | Pass |
| Freedom from extraneous | ||
| materials | Free from extraneous materials | Pass |
| Radioactivity |