(97 days)
Not Found
No
The summary describes a material (zirconia ceramic) used in dental restorations and the manufacturing process (CAD/CAM or manual milling). There is no mention of AI or ML being used in the device itself or in its intended use. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device is a material (zirconia ceramic) used to manufacture dental restorations like crowns and bridges. It does not directly provide a therapeutic effect; its purpose is to replace missing or damaged tooth structure.
No
Explanation: The device is described as a material (Dental Zirconia Ceramic) used for creating dental restorations (crowns, bridges, veneers, etc.) that are processed based on the anatomical rendering of a patient's teeth. It does not gather information from a patient to diagnose a condition.
No
The device description clearly states it is a physical material (zirconia ceramic) used for dental restorations, not a software program.
Based on the provided information, 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.) using CAD/CAM or manual milling. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a material (zirconia ceramic) used to build a physical structure. It doesn't analyze biological samples or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the material's physical properties (flexural strength, solubility, etc.) and biocompatibility, which are relevant for a dental restorative material, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a material used in the fabrication of a medical device (dental restoration).
N/A
Intended Use / Indications for Use
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe203+Er2O3+C03O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has six models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also 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 proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Biocompatibility Testing: The biocompatibility tests were performed according to ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry, and the test results showed that the proposed device has no biocompatibility issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented for performance testing according to ISO 6872:2015:
- Uniformity: Uniform
- Freedom from extraneous materials: Free from extraneous materials
- 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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December 6, 2022
Aidite (Qinhuangdao) Technology 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: K222626
Trade/Device Name: Dental Zirconia Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 31, 2022 Received: August 31, 2022
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.
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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 -S
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) K22626
Device Name Dental Zirconia Ceramic
Indications for Use (Describe)
Dental Zirconia Ceramic 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)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K222626
1. Contact Details
1.1 Applicant information
| Applicant Name | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address | No.9 Dushan Road, Economic and Technological Development Zone, Qinhuangdao City, Hebei, China |
| Contact person | Chen Yingying |
| Phone No. | +86-335-8357346 |
| chenyingying@aidite.com | |
| Date Prepared | 2022-08-25 |
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 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 卓远天成
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 Ceramic |
|---|---|
| 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 (Primary Predicate) |
|---|---|
| 510(k) Number | K183304 |
| Product Code | EIH |
| Manufacturer | ZIRKONZAHN SRL |
4. Device Description
Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments
4
(Fe203+Er2O3+C03O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has six models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also 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 proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
5. Intended Use/Indication for Use
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
6. Substantial Equivalence Comparison
| Comparison item | Proposed Device (K222626) | Predicate Device (K183304) | Comment |
|---|---|---|---|
| Manufacturer | Aidite (Qinhuangdao) Technology | ||
| Co., Ltd. | ZIRKONZAHN SRL | None | |
| Product Name | Dental Zirconia Ceramic | 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 | Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals. | 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 | Similar |
| 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 Stains 3D. Observe the relative 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, UTC, UTM
Class 5
Multilayer-3D pro, SHTPC, SHTPM | 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, UTC, UTM:
≥ 600 MPa | Prettau® 3, Prettau® 4 Anterior:
≥ 600 MPa | Similar |
| | Multilayer-3D pro, SHTPC,
SHTPM:
≥ 800 MPa | Prettau®, Prettau® 2, ICE group,
Z-White:
≥ 900 MPa | |
| 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).
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Product: Dental Zirconia Ceramic
| Test Item | Test Results | |||||
|---|---|---|---|---|---|---|
| Multilayer-3D | UTC | UTM | Multilayer-3D pro | SHTPC | SHTPM | |
| Uniformity | Uniform | Uniform | Uniform | Uniform | Uniform | Uniform |
| Freedom from | ||||||
| extraneous | ||||||
| materials | Free from | |||||
| extraneous | ||||||
| materials | Free from | |||||
| extraneous | ||||||
| materials | Free from | |||||
| extraneous | ||||||
| materials | Free from | |||||
| extraneous | ||||||
| materials | Free from | |||||
| extraneous | ||||||
| materials | Free from | |||||
| extraneous | ||||||
| materials | ||||||
| Radioactivity | ||||||
| (Bq.g-1) |