(282 days)
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 processed through dental laboratories or by dental professionals.
The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance. They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3). The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth. The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia 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 Blocks are provided as non-sterile.
The provided text describes the 510(k) summary for the "Dental Zirconia Blocks" device (K192262). This document focuses on demonstrating substantial equivalence to a predicate device, rather than performing a clinical study with acceptance criteria for a novel AI/software medical device.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details for an AI/software device cannot be extracted from this document.
This document describes a traditional medical device (dental zirconia blocks) and the testing performed is for physical and chemical properties, as well as biocompatibility, against established international standards.
For completeness, here's a summary of the testing performed and conclusions drawn from the provided text, adapted as much as possible to the prompt's structure, but it's important to reiterate that this is not an AI/software device study.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against various ISO standards. The document states that the proposed device "met all design specifications" and "complies with" these standards. The "acceptance criteria" are implied by the requirements of these standards.
| Acceptance Criteria (from referenced ISO standards) | Reported Device Performance (from text) |
|---|---|
| ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials | Complies with ISO 6872 |
| Flexural strength > 800MPa | > 800MPa |
| Solubility < 100 µg/cm² | < 100 µg/cm² |
| Radioactive uranium-238 active concentration ≤ 1.0 Bq/g | ≤ 1.0 Bq/g |
| ISO 10993-3: 2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Complies with ISO 10993-1:2018, FDA Guidance, tests included genotoxicity etc. |
| ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | Complies with ISO 10993-1:2018, FDA Guidance, tests included cytotoxicity |
| ISO 10993-6 Biological evaluation of the medical devices - Part 6: Tests for Local Effects after Implantation | Complies with ISO 10993-1:2018, FDA Guidance, tests included implantation effect |
| ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Complies with ISO 10993-1:2018, FDA Guidance, tests included oral mucosa irritation, skin sensitization |
| ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity | Complies with ISO 10993-1:2018, FDA Guidance, tests included acute systemic toxicity, subacute toxicity, subchronic systemic toxicity, pyrogenicity |
| Density (pre sintering) | ≥ 3.0 g / cm³ |
| Density (post sintering) | ≥ 6.02 g / cm³ |
| Sintering Temperature | 1400-1600 °C |
| Appearance Test | Performed, results not detailed but implied compliance |
| Dimension Test | Performed, results not detailed but implied compliance |
| Product composition | Performed, results not detailed but implied compliance (conforms to ISO 13356:2015) |
| Linear thermal expansion-coefficient | Performed, results not detailed but implied compliance |
| Fracture toughness | Performed, results not detailed but implied compliance |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each non-clinical test. The tests are for material properties and biocompatibility, not for evaluating an algorithm on a dataset of patient cases. Thus, "data provenance" in the sense of country of origin of patient data or retrospective/prospective is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert labels on medical images) is not relevant for the non-clinical testing of zirconia blocks, which involves laboratory measurements and chemical/biological assays.
4. Adjudication method for the test set
Not applicable. This is not a study involving expert readers or diagnostic classifications.
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
Not applicable. This is not an AI/software medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software medical device. The "standalone" performance here refers to the physical, chemical, and biological properties of the material itself.
7. The type of ground truth used
The "ground truth" for this device's evaluation is defined by the validated methods and specifications within the referenced ISO standards (e.g., methods for measuring flexural strength, solubility, density, and biocompatibility assays). Pathology or outcomes data are not mentioned.
8. The sample size for the training set
Not applicable. The concept of a "training set" is relevant for AI or machine learning models, which are not present in this submission.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI/ML training set.
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May 29, 2020
De Corematrix Co.Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, 200120 CHINA
Re: K192262
Trade/Device Name: Dental Zirconia Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 14, 2020 Received: March 2, 2020
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
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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 medical devices and radiation-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192262
Device Name Dental Zirconia Blocks
Indications for Use (Describe)
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 processed through dental laboratories or by dental professionals.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary, K192262
This summary of 510(k) substantial equivalence is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's Information
De Corematrix Co.Ltd. Name: Address: No.40 NanBeigang Road, HuKou County, JiuJiang, 332599 JiangXi,China Tel: 86-18379248893 Fax: 86-792-6322103 Contact: Kaixuan Liu Date of Preparation: May.28.2020
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Dental Zirconia Blocks Powder, Porcelain Common name: Classification name: Porcelain powder for clinical use
3.0 Classification
Production code: EIH Regulation number: 21 CFR 872.6660 Classification: Class II Panel: Dental
4.0 Identification of Predicate Device and Reference Device
Primary Predicate Device:
510(k) Number: K182068 Product Name: Erran Dental Zirconia Manufacturer: Hangzhou Erran Technology Co., Ltd.
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Reference Device:
510(k) Number: K141724 Product Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Liaoning Upcera Company Limited.
5.0 Indication for Use Statement
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. Blocks are processed through dental laboratories or by dental All professionals.
6.0 Device Description
The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance.
They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3).
The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth.
The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia 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 Blocks are provided as non-sterile.
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7.0 Non-Clinical Test Conclusion
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:
ISO 6872:2015/Amd1:2018 Dentistry - Ceramic Materials
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
8.0 Clinical Test Conclusion
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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| Item | Proposed deviceK192262 | Primary Predicatedevice K182068 | Reference deviceK141724 | Remark |
|---|---|---|---|---|
| Product Name | Dental Zirconia Blocks | Erran Dental Zirconia | Upcera Dental ZirconiaBlank & Dental ZirconiaPre-Shaded Blank | -- |
| Product Code | EIH | EIH | EIH | Same |
| Regulation No. | 872.6660 | 872.6660 | 872.6660 | Same |
| Class | II | II | II | Same |
| Intended Use | Dental Zirconia Blocks areintended for use for theproduction of artificial teethin fixed or removabledentures, or for jacketcrowns, facing, andveneers.All Blocks are processedthrough dental laboratoriesor by dental professionals. | Erran Dental ZirconiaBlocks are indicated forthe production of artificialteeth in fixed orremovable dentures, orfor jacket crowns, facing,and veneers.All Blocks are processedthought dentallaboratories or by dentalprofessionals. | Upcera Dental ZirconiaBlank & Dental ZirconiaPre-Shaded Blank areused for dentalrestorations using differentCAD/CAM or manualmilling machines.Allblanks are processedthought dental laboratoriesor by dental professionals. | Samewith thePredicateDevice |
| PrescriptionUse | Yes | Yes | Yes | Same |
| Shapes | Blocks, disc | Blocks, powder | Blocks, disc, and rod. | Same |
| Color | White and Colour | None | None,and pre-shaded | Analysis1 |
Table 6-1 General Device Characteristics Comparison Table
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| ChemicalComposition(Weight %) | White zirconia: | Zirconia(ZrO2+HfO2+Y2O3≥99.0) | Regular:Zirconia(ZrO2+HfO2+Y2O3+Al2O3≥99.0);Pre-Shaded:Zirconia(ZrO2+HfO2+Y2O3+Al2O3≥98.0)Inorganic pigments: Fe2O3+Pr2O3+Er2O3 <2.0 | Analysis1 | |
|---|---|---|---|---|---|
| ZrO2+HfO2+Y2O3 | ≥99.0 | ||||
| Y2O3 | 4.5 ~6.0 | ||||
| HfO2 | ≤5 | ||||
| Al2O3 | ≤0.5 | ||||
| Other oxide | ≤0.5 | ||||
| Colour zirconia: | |||||
| ZrO2+HfO2+Y2O3 | ≥98.0 | ||||
| Fe2O3 | <0.3 | ||||
| Pr2O3 | <0.2 | ||||
| Er2O3 | <1 | ||||
| Other oxide | ≤0.5 | ||||
| Dimension | Various | Various | Various | Same | |
| Density (presintering) | ≥ 3.0 g / cm³ | 3.10g/cm³ | 2.8~3.2 g/cm³ | Analysis2 | |
| Density (postsintering) | ≥ 6.02 g / cm³ | ≥ 6.02 g / cm³ | ≥ 6.02 g / cm³ | Same | |
| SinteringTemperature | 1400-1600 °C | 1350-1600°C | >1500°C | Analysis3 | |
| Flexuralstrength | > 800MPa | > 800MPa | ≥900 MPa | Samewith thePredicateDevice | |
| Solubility | <100 µg.cm-2 | <100µg/ cm² | <100µg/ cm² | Same |
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| Radioactive | uranium-238 activeconcentration ≤ 1.0 Bq / g. | The activity concentrationof U-238is not more than1.0 Bq / g. | Unknown | Samewith thePredicateDevice |
|---|---|---|---|---|
| Single Use | Yes | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| PerformanceTest | Including:Appearance Test,Dimension Test,Density Test,Product compositionFlexural strength,Linear thermalexpansion-coefficientChemical solubilityRadioactivity of dentalceramic,Fracture toughnesswhich comply with ISO6872 | Comply with ISO 6872 | Comply with ISO 6872 | Same |
| Biocompatibility | Comply with ISO10993-1:2018, FDAGuidance, tests includedcytotoxicity, oral mucosairritation, skin sensitization. | Comply with ISO10993-1, FDA Guidance | Comply with ISO 10993-1,FDA Guidance | Same |
| pyrogenicity, acutesystemic toxicity, subacutetoxicity, subchronicsystemic toxicity,implantation effect andgenotoxicity etc. | ||||
| Label andLabeling | Conforms to FDARegulatory Requirements | Conforms to FDARegulatory Requirements | Conforms to FDARegulatory Requirements | Same |
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Analysis:
The proposed device is highly similar to the predicate device in terms of indications for use, design, material and processing.
The proposed device is different from the predicate device in the following:
-
- The proposed device has white and colour zirconia blocks. The chemical compositions of white zirconia are same with that of predicate device. The chemical compositions of color zirconia are same with the that of reference device's pre-shaded zirconia blanks. The color is originated from inorganic pigments Fe2O3,Pr2O3 and Er2O3, that are of very small amount(<2.0%). All chemical ingredients in the proposed device have been used in the predicate device and the reference device. Accordingly, it was concluded that the proposed 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 and the reference device, but it has no obvious effect on the hardness, this difference does not affect substantial equivalence.
-
- The sintering temperature is about 1350-1600 ° for the predicated device, while this information is a little different with the proposed device which is about 1400-1600°C. This difference does not affect substantial equivalence as the sintering temperature mainly affects the physical and mechanical property of the dental blocks. Both the proposed and predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.
In summary, the main components of the proposed device and its predicate are substantially equivalent, and the slight differences does not affect the substantial equivalence of the proposed 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 proposed device and the predicated device are insignificant in terms of substantial equivalence. The proposed device is 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.