(58 days)
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
The subject device, Dental Zirconia Ceramic, are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all ceramic restorations such as veneers, inlay/ onlay, partial crowns,anterior crowns, posterior crowns. The ceramics material is composed of ZrO2, Y2O3 Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface, totally 16 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2,C3,C4,D2,D3,and D4), with the addition of very small amount ( < 0.5 % ) of inorganic pigments: Fe2O3 +Er2O3+C0304.
This document is a 510(k) Premarket Notification from the FDA regarding a dental device. It does not describe a study that uses AI or machine learning technology to interpret medical images or other diagnostic data. Instead, it concerns a physical dental material (Zirconia Ceramic) and its comparison to a predicate device based on physical and chemical properties.
Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, data provenance, number of experts establish ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the non-clinical tests that were performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Uniformity | Uniformly dispersed inorganic pigment(s) to produce color. | Product uniformity is qualified. Pass |
| Freedom from extraneous materials | Free from extraneous materials. | No extraneous materials. Pass |
| Radioactivity | Activity concentration of 238U not more than 1.0 Bq/g. | There was no activity detected. Pass |
| Flexural strength | Not less than 900 MPa. | Average 943.1 MPa. Pass |
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10^-6 K^-1. | Average 10.47 × 10^-6. Pass |
| Chemical solubility | Not more than 2000 µg/cm^2. (Note: Comparison table states <100 µg/cm^2) | Average 13.5. Pass |
| Product composition (%) | ZrO2 94%-95%; Y2O3 4.5%-5.5%; Al2O3 <0.5%; Other oxide <0.5%. | ZrO2: 94.56%; Y2O3: 5.34%; Al2O3: 0.005%; Other oxide: 0.095% |
Since this is a physical medical device submission (Dental Zirconia Ceramic) and not an AI/ML diagnostic or prognostic device, the following points are not applicable:
- Sample size used for the test set and the data provenance: Not applicable (no "test set" in the context of AI/ML). Tests were on physical material samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no "ground truth" established by experts in an AI/ML context).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the physical tests are the established ISO standards and observed physical/chemical properties.
- The sample size for the training set: Not applicable (no "training set" in the context of AI/ML).
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
January 7, 2022
Aidite (Qinhuangdao) Technology Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lu Jiazui Rd.,Pudong Shanghai, Shanghai 200120 CHINA
Re: K213570
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: November 8, 2021 Received: November 10, 2021
Dear Boyle Wang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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
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Indications for Use
510(k) Number (if known)
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 thought 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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K213570
510(k) Summary
This summary is submitted in accordance with 21 CFR 807.92.
1.0 Submission Sponsor
| Name: | Aidite (Qinhuangdao) Technology Co., Ltd. |
|---|---|
| Address: | No.9 Dushan Road,Economic and Technological Development Zone,Qinhuangdao City, China 066004 |
| Contact: | Wang Lili |
| Tel: | 86-335-8587198 |
| Fax: | 86-335-8587198 |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Address: | Shanghai Truthful Information Technology Co., Ltd.Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai200120 China |
| Tel: | +86-21-50313932 |
| Email: | info@truthful.com.cn |
Date of Preparation: Oct.8,2021
2.0 Device Information
Trade name: Dental Zirconia Ceramic Common name: Powder, Porcelain Classification name: Porcelain powder for clinical use Production code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Panel: Dental
3.0 Identification of Predicate Device and Reference Device
Predicate Device:
510(k) Number: K141724 Product Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Liaoning Upcera Company Limited.
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Reference Device:
510(k) Number: K210884 Product Name: 1Derful HS, 1Derful HT Manufacturer: 1DERFUL, INC.
4.0 Indication for Use Statement
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
5.0 Device Description
The subject device, Dental Zirconia Ceramic, are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all ceramic restorations such as veneers, inlay/ onlay, partial crowns,anterior crowns, posterior crowns. The ceramics material is composed of ZrO2, Y2O3 Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface, totally 16 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2,C3,C4,D2,D3,and D4), with the addition of very small amount ( < 0.5 % ) of inorganic pigments: Fe2O3 +Er2O3+C0304.
The composition of the Dental Zirconia Ceramic conforms to ISO 13356:2015, Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials.
The Dental Zirconia Ceramic is provided as non-sterile.
6.0 Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
| Items | Acceptance Criteria | Test Method | Test Result |
|---|---|---|---|
| Uniformity | The inorganic pigment(s) used to producethe colour of a fired dental ceramic shall beuniformly dispersed throughout the dentalceramic material. | Visual inspection | Product uniformityis qualified.Pass |
ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials
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| Freedom fromextraneousmaterials | Dental ceramic materials shall be free fromextraneous materials. | Visual inspection | No extraneousmaterials.Pass | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Radioactivity | Dental ceramic materials shall not have anactivity concentration of more than 1.0Bqg-1of 238U | ISO6872:2015/Amd1:2018 | There was noactivity detected.Pass | ||||||||||||||
| Flexuralstrength | The flexural strength of the product shouldnot be less than 900MPa. | ISO6872:2015/Amd1:2018 | Average 943.1MPaPass | ||||||||||||||
| Linear thermalexpansioncoefficient | The linear thermal expansion coefficientshould be (10.5±0.5) ×10-6 K-1. | ISO6872:2015/Amd1:2018 | Average 10.47 ×10-6Pass | ||||||||||||||
| Chemicalsolubility | The chemical solubility of the productshould not be more than 2000 ug.cm-2. | ISO6872:2015/Amd1:2018 | Average 13.5Pass | ||||||||||||||
| Productcomposition(%) | Item Requirements ZrO2 94%-95% Productcomposition(%) Y2O3 4.5%-5.5% Al2O3 <0.5% Other oxide <0.5% | ZrO2: 94.56%;Y2O3: 5.34%;Al2O3: 0.005%;Other oxide : 0.095% |
Biocompatibility Testing:
Biocompatibility testing per following standards are performed to verify the equivalent safety of the materials that are used:
ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-6 Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical device - Part 11: Tests for systemic toxicity
7.0 Summary of Clinical Test
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Clinical testing was not required for this submission.
9.0 Technological Characteristics and Substantial Equivalence
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
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| Summary |
|---|
| 510(k) |
| Image: S |
Table 1 General Device Characteristics Comparison Table
| Item | Subject Device | Predicate device | Reference device | Remark |
|---|---|---|---|---|
| 510(k) No. | Pending | K141724 | K210884 | -- |
| Product Name | Dental Zirconia Ceramic | Upcera Dental ZirconiaBlank & Dental ZirconiaPre-Shaded Blank | 1DERFULTM HS &1DERFULTM HT Zirconia | -- |
| Product Code | EIH | EIH | EIH | Same |
| Regulation No. | 872.6660 | 872.6660 | 872.6660 | Same |
| Class | II | II | II | Same |
| Intended Use | Dental Zirconia Ceramicare used for dentalrestorations using differentCAD/CAM or manualmilling machines. Allblanks are processedthought dental laboratoriesor by dental professionals. | Upcera Dental ZirconiaBlank & Dental ZirconiaPre-Shaded Blank areused for dentalrestorations using differentCAD/CAM or manualmilling machines.Allblanks are processedthought dental laboratoriesor by dental professionals. | 1DERFULTM HS &1DERFULTM HT Zirconiablanks are indicated for usein prosthetic dentistry tocreate porcelain (ceramic)prostheses (dentures,crowns and bridges).1DERFULTM HS &1DERFULTM HT Zirconiablanks are intended to bemilled and fully sinteredby a Dental Professional orDental Laboratory beforeuse. Full contour monolithiccrowns and bridges in | Samewith thePredicateDevice |
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| Stocks | Summary |
|---|---|
| 0(k) | |
| S |
| PrescriptionUse | Shapes | Color | Materials | Dimension | Density (presintering) | Density (postsintering) | SinteringTemperature | ||
|---|---|---|---|---|---|---|---|---|---|
| anterior and posteriorregions. Substructureceramic for prosthesesinvolving four or more unitscan be created. | Yes | Blocks | Colour | Zirconia (ZrO2: 94%~95%;Y2O3: 4.5%~5.5%Al2O3: <0.5%)Inorganic pigments: Fe2O3+Co3O4+Er2O3 <0.5 | Various | ≥2.80g / cm³ | ≥ 6.0g / cm³ | 1530 °C | SameAnalysis1 |
| Yes | Blocks, disc, and rod. | None, and pre-shaded | Regular:Zirconia(ZrO2+HfO2+Y2O3+Al2O3≥99.0);Pre-Shaded:Zirconia(ZrO2+HfO2+Y2O3+Al2O3≥98.0)Inorganic pigments: Fe2O3+Pr2O3+Er2O3 <2.0 | Various | 2.8~3.2 g/cm³ | ≥ 6.02 g / cm³ | >1500 °C | SameAnalysis1 | |
| Yes | Disc | None, and pre-shaded | ZrO2+HfO2 +Y2O3 > 99;HfO2: <2Y2O3: 5.2Al2O3: ≤ 0.05Inorganic pigments:Fe2O3 +ErO3 +Co3O4 & Er2O3 <0.3 | Various | Not Publicly available | 6.08 g/cm³ | SameAnalysis2 | ||
| SameAnalysis3 |
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| Summary | |
|---|---|
| ( | |
| 0(k | |
| l | |
| S |
| Flexuralstrength | > 900MPa | ≥900 MPa | >1000 MPa | Same |
|---|---|---|---|---|
| Solubility | <100 µg.cm-2 | <100µg/cm² | 5.257 µg/cm2 | Same |
| Radioactive | activeuranium-238concentration ≤ 1.0 Bq/g. | The activity concentrationof U-238is not more than1.0 Bq / g. | <0.03 | Same |
| Single Use | Yes | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| PerformanceTest | Including:Uniformity,Freedom fromextraneous materials,Radioactivity, Flexuralstrength, Linear thermalexpansion coefficient,Chemical solubilitywhich comply with ISO6872 | Comply with ISO 6872 | Comply with ISO 6872 | Same |
| Biocompatibility | Comply with ISO10993-1:2018,FDA Guidance, tests includedcytotoxicity, oral mucosairritation, skin sensitization,pyrogenicity, acutesystemic toxicity, subacutetoxicity, subchronictoxicity, | Comply with ISO 10993-1,FDA Guidance | Comply with ISO 10993-1,FDA Guidance | Same |
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510(k) Summary
| systemic toxicity, implantation effect and genotoxicity etc. |
|---|
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Analysis:
The subject device is highly similar to the predicate device in terms of indications for use, design, material and processing.
The subject device is different from the predicate device in the following:
-
- The subject device is color zirconia blocks. The chemical compositions of color zirconia are same with the that of reference device's pre-shaded zirconia. The color is originated from inorganic pigments Fe2O3, Co3O4 and Er2Os, that are of very small amount (<0.5%). All chemical ingredients in the subject device have been used in the predicate device and the reference device. Accordingly, it was concluded that the subject device is substantially equivalent in biocompatibility to the predicate device and the reference device.
-
- The pre sintering mainly affects the hardness of products which reflects the easy degree of material machining operations. The pre sintering density of the proposed device is a little different with the predicated device, but it has no obvious effect on the hardness, this difference does not affect substantial equivalence.
-
- The sintering temperature is >1500℃ for the predicated device, while this information is a little different with the subject device which is about 1530 ℃. This difference does not affect substantial equivalence as the sintering temperature mainly affects the physical and mechanical property of the dental blocks. Both the subject device and the predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.
In summary, the main components of the subject device and its predicate are substantially equivalent, and the slight differences does not affect the substantial equivalence of the subject device when compared to the predicate device.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the differences between the subject device and the predicate device are insignificant in terms of substantial equivalence. The proposed device is substantially equivalent to the predicate device.
§ 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.