(90 days)
Not Found
No
The device is a material (zirconia blank) used in the fabrication process, not a software or system that would typically incorporate AI/ML for analysis or decision-making. The description focuses on the material properties and manufacturing process.
No
The device is a material (zirconia blank) used for fabricating dental restorations, not a therapeutic device itself.
No
The device is a raw material (zirconia blank) used for fabricating dental restorations, not for diagnosing medical conditions. Its purpose is to become part of a prosthetic device, not to provide diagnostic information.
No
The device description clearly states it is a "Gradual Dental Zirconia Blank," which is a physical material (zirconia powder processed into blanks) used for fabricating dental restorations. It is 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 for the "fabrication of anterior and posterior dental restorations." This is a manufacturing process for creating physical dental prosthetics.
- Device Description: The device is a "Gradual Dental Zirconia Blank" which is a material used to create dental devices like crowns, facings, and veneers. It's a raw material that is machined and sintered.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (like blood, urine, or tissue) or provide information about a patient's health status.
- Focus on Fabrication: The entire description revolves around the process of fabricating dental restorations from the blank material.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks are processed through dental laboratories or by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
"Gradual Dental Zirconia Blank" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2, Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Gradual Dental Zirconia Blank" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Gradual Dental Zirconia Blank" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of fifty different colors, gradual changing translucencies, and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3); the different translucencies are originated from small difference in the amount of Y2O3, and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
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
dental laboratories or by dental professionals
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)
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of ISO 6872, and results met all relevant requirements in the test standard. Test results on radioactivity, thermal expansion, chemical solubility, and flexural strength of the subject device are very similar to the predicate device.
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.
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2023
Liaoning UPCERA CO., Ltd % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K231687
Trade/Device Name: Gradual Dental Zirconia Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 9, 2023 Received: June 9, 2023
Dear Charles Shen:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231687
Device Name Gradual Dental Zirconia Blank
Indications for Use (Describe)
The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks 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: K231687
This summary of substantial equivalence information for K231687 is being submitted in accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Liaoning Upcera Co., Ltd No.122 Xianghuai Road, Economic Development Zone, Benxi, Liaoning, China Tel: (086)-24-45565006 Submitter's FDA Registration Number: 3010582952 www.upcera-dental.com
5.2 Contact Person
Image /page/3/Picture/5 description: The image shows a logo with Chinese characters and a stylized letter "M". The letter "M" is formed by two blue triangles with a grainy texture, resembling a mountain range. Above the "M" is a curved, light blue shape, possibly representing a crescent moon or an arc. To the right of the arc are orange Chinese characters, adding a cultural element to the logo. The overall design is simple yet distinctive, likely representing a company or organization with a connection to China.
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: September 1, 2023
5.4 Device Name:
| Proprietary Name: | Gradual Dental Zirconia Blank |
|---|---|
| Common Name: | Dental Zirconia Ceramics |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: General | Dental |
| Product Code: | EIH |
ર્સ્ડ Predicate Device Information:
K152175, "Dental Zirconia Blank for Aesthetic Restoration", manufactured by "Liaoning Upcera Co., Ltd." (Primary predicate)
5.6 Device Description:
"Gradual Dental Zirconia Blank" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket
4
crowns, facings, and veneers. The zirconia powder is composed of ZrO2 , Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Gradual Dental Zirconia Blank" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Gradual Dental Zirconia Blank" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of fifty different colors, gradual changing translucencies, and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3); the different translucencies are originated from small difference in the amount of Y2 O3, and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
5.7 Indications for Use:
The device is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All blanks are processed through dental labora tories or by dental professionals.
5.8 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
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| Description | Subject Device | Predicate Device (K152175) |
|---|---|---|
| Indication for | ||
| Use | For fabrication of anterior and posterior d | |
| ental restorations using different CAD/C | ||
| AM or manual machines. | ||
| All blanks are processed through dental la | ||
| boratories or by dental professionals. | Is mainly used in prosthetic treatment. | |
| While the flexural strength of Dental | ||
| Zirconia Ceramics after sintering is | ||
| between 300-500 MPa, the product can | ||
| be used for veneering, inlay, single | ||
| crown, and substructure ceramic for | ||
| three-unit prostheses not involving | ||
| molar restoration; While the flexural | ||
| strength of Dental Zirconia Ceramics | ||
| after sintering is over 500 MPa, it can | ||
| be used for veneering, inlay, single | ||
| crown, and substrate ceramic for three- | ||
| unit prostheses. | ||
| Basic Design | Blocks, disc, and rod | Blocks, disc, and rod |
| Materials | Zirconia ( $ZrO_2 + Y_2O_3 + HfO_2 \ge 98%$ ) | |
| Inorganic pigments | Zirconia ( $ZrO_2 + Y_2O_3 + HfO_2$ ) ≥ 98%) | |
| Inorganic pigments | ||
| Processing | Sintering at temperature > 1400 °C | Sintering at temperature > 1400 °C |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Shade | Fifty colors, one aesthetic effects, and | |
| gradual change of translucency effect | Forty six colors, two aesthetic effects: | |
| single and multilayer effect, and three | ||
| translucency effects | ||
| Sterile | Non-sterile | Non-sterile |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
There are wording differences in the indications for use statement between the subject and predicate devices, but the expressed indications essentially have the same meaning. Both devices are intended to be used in the prosthetic treatment and dental restorations. Anterior and posterior dental restorations (as stated for the subject device) include veneering, inlay, single crown, and substrate ceramic for multiple unit prostheses (as stated for the predicate device).
Our device is also essentially identical to the predicate device in terms of design, material, and processing between our device and the predicate devices. The minor differences do not raise any safety and effectiveness concerns.
રું. તે તે તે તે તે તે પ્રતિષ્ઠા તાલુકામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે ખાતે ખાતે ખેતી કરવામાં આવેલું એક ગામનાં મુખ્યત્વે ખેત-ઉત Comparison of Performance with Predicate Device
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of ISO 6872, and results met all relevant requirements in the test standard. Test results on radioactivity, thermal expansion,
6
chemical solubility, and flexural strength of the subject device are very similar to the predicate device.
Since "Gradual Dental Zirconia Blank" uses the same material, same composition, same manufacture process as its predicate device, K152175, the biocompatibility of the subject device has been established.
Summary of Non-Clinical Testing: 5.10
Bench testing was performed per ISO 6872:2008 and internal procedures to ensure that the "Gradual Dental Zirconia Blank" met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalence of the materials that are used.
5.11 Summary of Clinical Study:
Clinical Study is not performed for this device.
5.12 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "Gradual Dental Zirconia Blank" and its predicate devices have similar indications for use, similar composition, and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "Gradual Dental Zirconia Blank" and their predicate device do not raise any question regarding its equivalence.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the subject device is respectively substantially equivalent to the predicate device.