(143 days)
The Ceramic Denture Zirconia Ceramics Block are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
The Ceramic Denture Zirconia Ceramics Block are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Ceramic Denture Zirconia Ceramics Block conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The Ceramic Denture Zirconia Ceramics Block are offered in four (4) different product families of shapes and a multitude of different sizes and are capable of being machined into complex dental shapes using modern machining methods.
The provided document is a 510(k) premarket notification for a medical device, specifically Ceramic Denture Zirconia Ceramics Block. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device rather than proving clinical efficacy through extensive studies that align with acceptance criteria typically seen in AI/ML device submissions.
Therefore, the information requested about acceptance criteria and study details (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training set details) is not applicable to this type of regulatory submission for this device.
Instead, the document details the device's physical and chemical properties and verifies its compliance with recognized international standards (ISO).
Here's the relevant information that can be extracted, formatted as requested where possible, but with the understanding that the "acceptance criteria" here refers to meeting established standards and physical properties:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric/Standard | Reported Device Performance |
|---|---|---|
| Composition | ZrO2 | < 96 % wt |
| Y2O3 | >4% | |
| HfO2 | >1% | |
| Al2O3 | <1% | |
| Physical/Mechanical Properties | Crystal Morphology | Tetragonal |
| Color | Non-shaded | |
| Density (pre-sintering) | 2.8 - 3.2 g/cm³ | |
| Density (post-sintering) | ≥ 6 g/cm³ | |
| Fracture Toughness (post-sintering) | ≥ 900 Mpa (Note: Table 7 shows "Bending Strength ≥ 900 MPa") | |
| Sintering Temperature | 1530 °C (for full density and strength) | |
| Porosity | ≤ 0.1% | |
| Bending Strength (Post-sintering, implied from ISO 6872) | ≥ 900 MPa (Stated in comparison as "Bending Strength of proposed device is ≥900 MPa") | |
| Solubility (Implied from ISO 6872) | ≤ 100 ug/cm³ | |
| Material Standards | Compliance with ISO 6872:2015 (Dentistry - Ceramic Materials) | Complies |
| Biocompatibility Standards | Compliance with ISO 10993-1 | Complies |
| Compliance with ISO 10993-3 (Genotoxicity, carcinogenicity, reproductive toxicity) | Complies | |
| Compliance with ISO 10993-5 (In Vitro cytotoxicity) | Complies | |
| Compliance with ISO 10993-10 (Irritation and skin sensitization) | Complies | |
| Compliance with ISO 10993-11 (Systemic toxicity) | Complies |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission does not involve a "test set" in the context of an AI/ML device evaluating data. The testing performed focuses on the physical, chemical, and biological properties of the material itself, typically using a sufficient number of samples as prescribed by the relevant ISO standards to ensure statistical validity for material characterization. The document does not specify exact sample sizes for each physical test but asserts compliance with the standards, which inherently include sampling requirements.
- Data Provenance: The tests were conducted internally by the manufacturer, Qinhuangdao Silide Ceramic Technology Co., Ltd., to demonstrate compliance with ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this material science submission. Compliance with ISO standards for material properties (e.g., density, strength, biocompatibility) is determined by laboratory testing measurements against predefined standard thresholds, not by expert interpretation or consensus.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for reconciling differences in expert interpretations, which is not part of this material testing.
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. No MRMC study was performed as this is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a material (zirconia block) for dental restorations, not a standalone algorithm.
7. The type of ground truth used
- Objective Measurement against Standards: The "ground truth" for this device's performance is established by objective laboratory measurements of physical, mechanical, and chemical properties (e.g., density, bending strength, chemical solubility, composition) compared against the quantitative requirements and thresholds specified in international standards such as ISO 6872:2015 and ISO 10993 series.
- Biocompatibility "ground truth" is established through testing following ISO 10993 guidelines, demonstrating that the material does not induce adverse biological responses.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November.29.2018
Qinhuangdao Silide Ceramic Technology Co., Ltd % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 CN
Re: K181816
Trade/Device Name: Ceramic Denture Zirconia Ceramics Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 25, 2018 Received: October 31, 2018
Dear Ray 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Mary S. Runner Digitally signed by Mary S. Runner -S3 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------53
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181816
Device Name
Ceramic Denture Zirconia Ceramics Block
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Ceramic Denture Zirconia Ceramics Block are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------- |
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-
- Date of Preparation
11/29/2018
- Date of Preparation
-
Sponsor 2.
Qinhuangdao Silide Ceramic Technology Co., Ltd.
No. 1 Yanghe Road ,Qinhuangdao Economic and Technological Development Zone, Hebei province, China 066000 Contact Person: Lou ChunHua Position: General Manager Tel: +86 335 7675829 Fax: +86 335 7675824 Email: Qhdsld0335@126.com
- Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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- Trade/Classification Name Trade Name of Subject device: Ceramic Denture Zirconia Ceramics Block Classification Name: Porcelain Powder for Clinical Use Common Name: Powder, Porcelain Classification: 2; Product Code: EIH; Regulation Number: 21 CFR 872.6660; Review Panel: Dental:
-
- Identification of Predicate Device
Predicate Device: 510(k) Number: K172761 Product Name: New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) Manufacturer: Shanghai New Century Dental Materials Co., Ltd.
- Identification of Predicate Device
-
Indication For Use 6.
The Ceramic Denture Zirconia Ceramics Block are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
7. Device Description
Trade Name of Subject device: Ceramic Denture Zirconia Ceramics Block
The Ceramic Denture Zirconia Ceramics Block are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Ceramic Denture Zirconia Ceramics Block conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
The Ceramic Denture Zirconia Ceramics Block are offered in four (4) different product families of shapes and a multitude of different sizes and are capable of being machined into complex dental shapes using modern machining methods.
| Family | Shapes & Sizes Available |
|---|---|
| KC-Cercon System | Blocks: 20 x 26.5 x25, 20 x 50 x 25, 20 x 60x25, 20 x 65 x25, 25 x 43 x 16, 36 x 75 x 16 |
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| (mm). | |
|---|---|
| KZ-Zirkonzahn System | Discs: 95 x 10, 95 x 12, 95 x 14, 95 x 16, 95 x 18, 95 x 20, 95 x 22, 95 x 25, 98 x 10, 98 x 12, 98 x 14, 98 x 16, 98 x 18, 98 x 20, 98 x 22, 98 x 25,100 x 10, 100 x 12, 100 x 14, 100 x 16, 100 x 18, 100 x 20, 100 x 22, 100 x 25 (mm) |
| KA-Amann Girrbach System | U Shaped: 90 x 71 x 12, 90 x 71 x 14, 90 x 71 x 16, 90 x 71 x 18, 90 x 71 x 20, 90 x 71 x 22, 90 x 71 x 25 (mm) |
| KK-KAVA System | Blocks: 20 x 42 x 16, 16 x 42 x 16, 16 x 60 x 20 (mm)Rods: 16 x 16, 20 x 20 (mm) |
Accessories/Components: The blocks are only item in the final/sale package, no other accessories/components associated with the proposed device.
Device Composition
| ZrO2 | < 96 % wt |
|---|---|
| Y203 | >4% |
| HfO2 | >1% |
| Al203 | <1% |
The Ceramic Denture Zirconia Ceramics Block are derived from zirconia powder that has been processed via axial die pressing, and followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The Ceramic Denture Zirconia Ceramics Block are nonshaded, no colorants or fillers included in proposed device. The Ceramic Denture Zirconia Ceramics Block are disposable device, and provided as non-sterile.
Physical and mechanical properties for Ceramic Denture Zirconia Ceramics Block are shown in following table and are similar in nature to the predicate device.
| ZrO2 | < 96 % wt |
|---|---|
| Y203 | >4% |
| HfO2 | >1% |
| A1203 | <1% |
| Crystal Morphology | Tetragonal |
| Color | Non-shaded |
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| Density (pre sintering) | 2.8 - 3. 2 g/cm3 |
|---|---|
| Density (post sintering) | $\ge$ 6 g/cm3 |
| Fracture Toughness (post sintering) | $\ge$ 900 Mpa |
| Sintering temperature | 1530 °C |
| Porosity | $\le$ 0.1% |
Machining of Ceramic Denture Zirconia Ceramics Blocks should be carried out by qualified and trained dental professionals using appropriate CAD/CAM equipment found in professional dental restoration labs. At the time of fabrication, all associated fabrication equipment should be properly calibrated and serviced according to the machine's operators manual. When designing crowns and bridges using Ceramic Denture Zirconia Ceramics Blocks, the following minimum dimensions must be maintained:
Minimum wall thickness for anteriors: 0.4 mm
Minimum wall thickness for posteriors: 0.6 mm
Minimum section of connectors for posteriors (for three unit bridges): 9 mm2
Upon completion of the CAD/CAM machining processes of the porous blanks, the dental device (i.e., crown or bridge) must be oven sintered to achieve its full density and strength to harden the ZrO2 as detailed below.
Post-Fabrication Sintering Instructions: Firing Times & Temperatures: RT to 300 degrees C: 1hr 300 to 1000 degrees C: 1hr 1000 to 1530 degrees C: 3hrs 1530 degrees C: 2 hrs Cooling Cycle to 100 Degree C: 5 hours
Post-Sintering Instructions:
Upon completion of the sintering process, crowns and bridges can also be sandblasted with 110 micrometer corundum sand with 4 bar pressure for about 5 seconds. The crown is treated with porcelain before placed in the patient's mouth.
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8. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
| ITEM | Proposed Device (K181816) | Predicate Device (K172761) | Remark |
|---|---|---|---|
| Product Code | EIH | EIH | SE |
| Regulation No. | 21 CFR 872.6660 | 21 CFR 872.6660 | SE |
| Class | II | II | SE |
| Intended Use | The Ceramic Denture Zirconia CeramicsBlock are intended for use withCAD/CAM technology to produce allceramic dental restorations (full contourcrowns, bridges, inlays, and Veneers) asprescribed by a dentist. | New Century All-Ceramic DentalZirconia Blocks (Un-Shaded &Pre-Shaded) are Intended for use withCAD/CAM technology to produce allceramic dental restorations (full contourcrowns, bridges, inlays, and Veneers) asprescribed by a dentist. | SE |
| Shapes | Blocks, Disc, Rod, and U-shaped | Blocks, Disc, and Rod | Analysis 1 |
| Materials | ZrO2+Y2O3+HfO2+Al2O3Meet the requirements of ISO 6872 | ZrO2+Y2O3+HfO2+Al2O3Meet the requirements of ISO 6872 | SE |
| Processing | Sintering at temperature around 1500 ℃ | Sintering at temperature around 1500 ℃ | SE |
| Dimension | KC-Cercon System,20 x 26.5 x25, 20 x 50 x 25, 20 x 60 x25,20 x 65 x25, 25 x 43 x 16, 36 x 75 x 16(mm).KZ-Zirkon zahn System95 x 10, 95 x 12, 95 x 14, 95 x 16, 95 x 18,95 x 20, 95 x 22, 95 x 25, 98 x 10, 98 x 12,98 x 14, 98 x 16, 98 x 18, 98 x 20, 98 x 22,98 x 25,100 x 10, 100x12, 100 x14, 100x16, 100 x 18, 100 x 20, 100 x 22, 100 x25 (mm)KA-Amann Girrbach SystemU Shaped: 90 x 71 x 12, 90 x 71 x 14, 90 x71 x 16, 90 x 71 x 18, 90 x 71 x 20, 90 x71 x 22, 90 x 71 x 25 (mm)KK-KAVA SystemBlocks: 20 x 42 x16, 16x 42 x 16, 16 x 60x 20 (mm)Rods: 16 x 16, 20 x20 (mm) | Various | Analysis 2 |
| Density | > 6 g/cm3 | N.A. | Analysis 3 |
| Sintering | 1530 ℃ | 1500 ℃ | Analysis 4 |
| Temperature | |||
| BendingStrength | $\ge$ 900 MPa | N.A. | Analysis 5 |
| Solubility | $\le$ 100 ug/cm3 | N.A. | Analysis 6 |
| Single Use | Yes | Yes | SE |
| Color | Non-shaded | None, and Pre-shaded (for pre-shadedseries) | SE |
| Sterile | Non-sterile | Non-sterile | SE |
| PerformanceTest | Comply with ISO 6872Appearance Test;Dimension TestRadioactivity TestDensity TestBend strength testChemical Solubility test;Porosity test;Coefficient of linear expansion testFracture toughness test;Material ingredients test; | Comply with ISO 6872 | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label andLabeling | Conforms to FDA RegulatoryRequirements | Conforms to FDA RegulatoryRequirements | SE |
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The proposed device is highly similar to the predicate device in terms of indications for use, design, material, processing and color. The proposed device is different from the predicate device in the following:
-
- The subject device has blocks, disc, U-shaped and rod, while the predicate device only has blocks, disc and rod. This difference does not raise any safety or efficacy concerns for two reasons: First, the initial product shape does not matter because they are going to be milled into the final shape before patient use. Secondly, all device with different shapes share materials and manufacturing process, so they have same performance in physical, mechanical and biocompability.
-
- The subject device has different size used to predicate device. All proposed device sizes are going to be milled into the final shape before patient use, and all device sizes share same materials and manufacturing process, so they have same performance in physical, mechanical and biocompability.
-
- The subject device has different Density to predicate device. Since this performance value of predicate device is not available in the predicate device's 510K summary, so we consider it as different. The density of proposed device is > 6 g/cm3, which is same with lots of device has been cleared by FDA, such as K160367, K180252. Those devices all have similar indication for use and materials with proposed device.
-
- The subject device has different Sintering Temperature to predicate device, 1530 vs. 1500. Both the subject and predicate device have similar physical/mechanical properties that meet the requirement of ISO 6872.
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-
- The subject device has different Bending Strength to predicate device. Since this performance value of predicate device is not available in the predicate device's 510K summary, so we consider it as different. The Bending Strength of proposed device is ≥900 MPa, which is meet the requirements of ISO6872.
-
- The subject device has different Solubility to predicate device. Since this performance value of predicate device is not available in the predicate device's 510K summary, so we consider it as different. The Solubility mainly affected by the materials composition, and the proposed device has same materials composition with the predicate device, then they shall have similar solubility performance. And also the Solubility will mainly affects the physical and mechanical property of the dental blanks and both the subject and predicate device have similar physical/mechanical properties that met the requirements of ISO 6872.
-
- 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 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 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2006 Biological evaluation of medical device – Part 11: Tests for systemic toxicity.
-
- Clinical Test Conclusion
No Clinical Test conducted.
- Clinical Test Conclusion
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- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is Substantially Equivalent as the predicate device.
- Substantially Equivalent (SE) Conclusion
§ 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.