(143 days)
No
The summary describes a ceramic block material used with CAD/CAM technology, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a raw material (ceramic block) used to produce dental restorations, which are prosthetic devices, not therapeutic devices.
No
The device is described as a material (zirconia ceramic blocks) used with CAD/CAM technology to produce dental restorations like crowns and bridges, which are treatment devices, not diagnostic ones.
No
The device is a physical ceramic block intended for use with CAD/CAM technology to produce dental restorations. It is a material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce dental restorations (crowns, bridges, inlays, veneers) for patients, as prescribed by a dentist. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material (zirconia ceramic block) used in the fabrication of dental prosthetics. It's a component of a manufacturing process for a medical device that is implanted or placed in the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used to create a physical restoration for a patient's teeth.
N/A
Intended Use / Indications for Use
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.
Product codes
EIH
Device Description
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 Ceramic Denture Zirconia Ceramics Block are non-shaded, no colorants or fillers included in proposed device. The Ceramic Denture Zirconia Ceramics Block are disposable device, and provided as non-sterile.
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
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.
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)
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.
No Clinical Test conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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:
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- 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 60 |
| x25, 20 x 65 x25, 25 x 43 x 16, 36 x 75 x 16 |
5
| (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 | 4% |
| HfO2 | >1% |
| Al203 | 4% |
| HfO2 | >1% |
| A1203 | 6 g/cm3 | N.A. | Analysis 3 |
| Sintering | 1530 ℃ | 1500 ℃ | Analysis 4 |
| Temperature | | | |
| Bending
Strength | $\ge$ 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-shaded
series) | SE |
| Sterile | Non-sterile | Non-sterile | SE |
| Performance
Test | Comply with ISO 6872
Appearance Test;
Dimension Test
Radioactivity Test
Density Test
Bend strength test
Chemical Solubility test;
Porosity test;
Coefficient of linear expansion test
Fracture toughness test;
Material ingredients test; | Comply with ISO 6872 | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Label and
Labeling | Conforms to FDA Regulatory
Requirements | Conforms to FDA Regulatory
Requirements | 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.
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- 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.
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- 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.
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- 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