(97 days)
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.
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.
This FDA 510(k) summary describes a Dental Zirconia Ceramic device (K222626) and its comparison to a predicate device (K183304). The submission focuses on non-clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dental Zirconia Ceramic are based on the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials. The reported device performance is presented as test results against these criteria.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Worst Case/Range) |
|---|---|---|
| Uniformity | Uniform | Uniform (for all models: Multilayer-3D, UTC, UTM, Multilayer-3D pro, SHTPC, SHTPM) |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials (for all models) |
| Radioactivity (Bq.g-1) | ≤ 1.0 (from comparison table, implied acceptance) | <0.021 (range: <0.018 to <0.021 for all models) |
| Flexural Strength (Mpa) (Class 4) | ≥ 600 MPa (for Multilayer-3D, UTC, UTM models) | 635.60 (Multilayer-3D, Incisal end) to 840.69 (UTC) to 725.34 (UTM). All values meet or exceed 600 MPa for these models. |
| Flexural Strength (Mpa) (Class 5) | ≥ 800 MPa (for Multilayer-3D pro, SHTPC, SHTPM models) | 985.15 (Multilayer-3D pro) to 950.95 (SHTPC) to 1014.51 (SHTPM). All values meet or exceed 800 MPa for these models. |
| Chemical Solubility (µg/cm²) | < 100 µg/cm² | 5 (SHTPM) to 38 (Multilayer-3D pro) (range: 5 to 38 for all models) |
| Linear Thermal Expansion Coefficient (×10-6 K-1) | Not explicitly stated as acceptance criteria, but predicate comparison shows Not publicly available for predicate. | Incisal end: 10.4, Middle part: 10.3, Root end: 10.3 (Multilayer-3D); 10.1 (UTC); 10.5 (UTM); 10.5 (Multilayer-3D pro); 10.3 (SHTPC); 10.4 (SHTPM) |
| Biocompatibility | Compliant with ISO 7405:2018 and specific ISO 10993 standards | No cytotoxicity, no skin sensitization, no oral mucosa irritation, no acute or subchronic systemic toxicity, no genotoxicity, no local effects from implantation. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of samples for flexural strength, radioactivity, etc.). It only states that "Performance tests were performed according to ISO 6872:2015". ISO standards often define minimum sample sizes for specific tests.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data. However, the applicant is Aidite (Qinhuangdao) Technology Co., Ltd. from China, so it is reasonable to infer the tests were conducted or overseen by them, likely in China or at a facility compliant with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device's performance is evaluated against material standards (ISO 6872:2015), not against human interpretation or diagnosis. Therefore, there is no "ground truth" established by experts in the context of medical image analysis or similar applications. The results are objective measurements.
4. Adjudication method for the test set
This section is not applicable as the evaluation is based on objective material property measurements against an international standard, not expert review or diagnostic assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This submission is for a dental material (zirconia ceramic), not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a material device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical testing is the established scientific and engineering principles and measurement methodologies defined in international standards, specifically ISO 6872:2015 for ceramic materials and various ISO 10993/7405 standards for biocompatibility. The compliance is measured against the specifications and test methods outlined in these standards.
8. The sample size for the training set
This section is not applicable. The submission is for a manufactured material product, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable as there is no training set.
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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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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., Ltd1713A, 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
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(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) TechnologyCo., Ltd. | ZIRKONZAHN SRL | None |
| Product Name | Dental Zirconia Ceramic | PRETTAU®, ICE and Z-WHITEzirconia blanks | None |
| Product Code | EIH | EIH | Same |
| RegulationNumber | 21 CFR § 872.6660 | 21 CFR § 872.6660 | Same |
| Classification | Class II | Class II | Same |
| Prescription Use | Yes | Yes | Same |
| Indications forUse | 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 4Multilayer-3D, UTC, UTMClass 5Multilayer-3D pro, SHTPC, SHTPM | Class 4Prettau® 3, Prettau® 4 AnteriorClass 5Prettau®, 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 |
| PhysicalProperties | Conform to ISO 6872:2015 | Conform to ISO 6872:2015 | Same |
| Uniformity | Uniform | Uniform | Same |
| Freedom fromextraneousmaterials | Free from extraneous materials | Free from extraneous materials | Same |
| Radioactivity | ≤ 1.0 Bq.g-1 | ≤ 1.0 Bq.g-1 | Same |
| Flexuralstrength | 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 | ||
| Chemicalsolubility | < 100 µg/cm² | < 100 µg/cm² | Same |
| Linear thermalexpansioncoefficient | Multilayer-3D, Multilayer-3D pro,SHTPM:(10.4±0.5)×10-6 K-1SHTPC:(10.3±0.5)×10-6 K-1UTC:(10.0±0.5)×10-6 K-1UTM:(10.5±0.5)×10-6 K-1 | Not publicly available | Different |
| Biocompatibility | Conform to ISO 7405:2018 | ||
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
Table 1 Substantial Equivalence Comparison
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Product: Dental Zirconia Ceramic
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, the proposed device is substantially equivalent to the predicate device.
7. 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).
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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 fromextraneousmaterials | Free fromextraneousmaterials | Free fromextraneousmaterials | Free fromextraneousmaterials | Free fromextraneousmaterials | Free fromextraneousmaterials | Free fromextraneousmaterials |
| Radioactivity(Bq.g-1) | <0.019 | <0.018 | <0.019 | <0.021 | <0.020 | <0.019 |
| Flexural strength(Mpa) | Incisal end: 635.60Middle part: 804.40Root end: 931.30 | 840.69 | 725.34 | 985.15 | 950.95 | 1014.51 |
| Linear thermalexpansioncoefficient(×10-6 K-1) | Incisal end: 10.4Middle part: 10.3Root end: 10.3 | 10.1 | 10.5 | 10.5 | 10.3 | 10.4 |
| Chemical solubility(µg/cm²) | 28 | 11 | 21 | 38 | 13 | 5 |
| Shrinkage factor | 1.233 | 1.244 | 1.237 | 1.234 | 1.241 | 1.250 |
Table 2 Summary of Performance Testing
A 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.
| Biological Endpoint | Reference | Test Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 | No cytotoxicity under the conditions of the study |
| Cytotoxicity | ISO 7405:2018, 6.2 | No cytotoxicity under the conditions of the study |
| Cytotoxicity | ISO 7405:2018, 6.3 | 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 |
Version: A/0
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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).
§ 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.