(122 days)
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No
The document describes a material (zirconia blanks) used in CAD/CAM processes for dental restorations. There is no mention of AI or ML being used in the material itself or in its manufacturing process as described. The CAD/CAM process is mentioned, but this refers to computer-aided design and manufacturing, not necessarily AI/ML-driven design or manufacturing.
No.
The device is a material (zirconia blanks) used to fabricate prosthetic dental devices (artificial teeth), which are used in prosthetic treatment, rather than being a therapeutic device itself.
No
The device is a "Dental Zirconia Blank for Aesthetic Restoration," which is a material used to fabricate dental prostheses. It does not perform any diagnostic function.
No
The device is a physical dental blank made of zirconia powder, not software. The description details its material composition, manufacturing process, and physical forms (blocks, discs, etc.). While it is used in conjunction with CAD/CAM machining (which involves software), the device itself is a tangible material.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic treatment" and the creation of "artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers." This is a structural and restorative application, not a diagnostic one.
- Device Description: The device is a "ceramic dental blank" used to fabricate dental prosthetic devices through CAD/CAM machining and sintering. It's a material used in the creation of a physical restoration.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on material properties like flexural strength, density, and biocompatibility, which are relevant to the structural integrity and safety of a dental restoration, not a diagnostic test.
In summary, the "Dental Zirconia Blank for Aesthetic Restoration" is a material used in the manufacturing of dental prosthetics, which are medical devices, but they are not IVDs.
N/A
Intended Use / Indications for Use
"Dental Zirconia Blank for Aesthetic Restoration" is mainly used in prosthetic treatment. When the flexural of Dental Zirconia Blank for Aesthetic Restoration 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; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. 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
"Dental Zirconia Blank for Aesthetic Restoration" 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 + Y2 O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Blank for Aesthetic Restoration" 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.
"Dental Zirconia Blank for Aesthetic Restoration" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty-six different colors, three different translucencies, and two different aesthetic effects (single and multilayer).
The different colors are originated from the different constituent of color additives (such as Fe203, Er202); the different translucencies are originated from small difference in the amount of Y2 O3, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental laboratories or by dental professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed per ISO 6872:2008 and internal procedures to ensure that the "Dental Zirconia Blank for Aesthetic Restoration" 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2015
Liaoning Upcera Co., Ltd. c/o Mr. Charles Shen Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K152175
Trade/Device Name: Dental Zirconia Blank for Aesthetic Restoration Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 1, 2015 Received: November 3, 2015
Dear Mr. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K152175
Device Name
Dental Zirconia Blank for Aesthetic Restoration
Indications for Use (Describe)
"Dental Zirconia Blank for Aesthetic Restoration" is mainly used in prosthetic treatment. When the flexural of Dental Zirconia Blank for Aesthetic Restoration 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; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. 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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K152175
510(k) Summary:
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
Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: December 1, 2015
| Device Name: | |
|---|---|
| Proprietary Name: | Dental Zirconia Blank for Aesthetic Restoration |
| Common Name: | Dental Zirconia Ceramics |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: General | Dental |
| Product Code: | EIH |
Predicate Device Information:
- K093560, "Upcera Zirconia Blanks", manufactured by "Shenyang . Upcera Co., Ltd."
Device Description:
"Dental Zirconia Blank for Aesthetic Restoration" 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 + Y2 O3 +
4
HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Blank for Aesthetic Restoration" 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.
"Dental Zirconia Blank for Aesthetic Restoration" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty-six different colors, three different translucencies, and two different aesthetic effects (single and multilayer).
The different colors are originated from the different constituent of color additives (such as Fe203, Er202); the different translucencies are originated from small difference in the amount of Y2 O3, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing.
Intended Use:
"Dental Zirconia Blank for Aesthetic Restoration" is mainly used in prosthetic treatment. When the flexural strength of Dental Zirconia Blank for Aesthetic Restoration 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; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. All blanks are processed through dental laboratories or by dental professionals.
Summary of Device Testing:
Bench testing was performed per ISO 6872:2008 and internal procedures to ensure that the "Dental Zirconia Blank for Aesthetic Restoration" 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.
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 (K152175) | Predicate Device (K093560) |
|---|---|---|
| Indications for | ||
| Use | "Dental Zirconia Blank for Aesthetic Restoration" is | |
| mainly used in prosthetic treatment. When the | ||
| flexural strength of Dental Zirconia Blank for | ||
| Aesthetic Restoration 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; when the flexural strength of Dental | ||
| Zirconia Blank for Aesthetic Restoration after | ||
| sintering is over 500 MPa, it can be used for | ||
| veneering, inlay, single crown, and substrate | ||
| ceramic for three-unit prostheses. All blanks are | ||
| processed through dental laboratories or by dental | ||
| professionals. | Upcera Zirconia Blanks are indicated for | |
| dental restorations using different | ||
| CAD/CAM or manual milling machines. | ||
| All blanks are processed through dental | ||
| laboratories or by dental professionals. | ||
| Basic Design | Blocks, disc, and rod | Blocks, disc, and rod |
| Materials | Zirconia (ZrO2 + Y2 O3 + HfO2 + Al2O3≥ | |
| 98%) | ||
| Inorganic pigments | Zirconia (ZrO2 + Y2O3 + HfO2 + | |
| Al2O3 ≥ 99.0%) | ||
| Processing | Sintering at temperature > 1400 °C | Sintering at temperature > 1500 °C |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Color | Forty six colors, three translucencies, and two | |
| different aesthetic effects (single and multilayer) | None | |
| Sterile | Non-sterile | Non-sterile |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
Our device is equivalent to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. Slight differences are also noted between the subject and predicate devices. First, the subject device and predicate device have different Indications for Use language. The subject device is specific regarding the application based on the flexural strength; however, both devices are equivalent, in terms of intended use. Both devices are intended to be used for dental restorations using CAD/CAM or manual milling machines, and are to be processed by dental professionals.
The most important difference noted between the subject and predicate devices relates to physical properties. The predicate device has no color, while our proposed device has both the white regular one and pre-shaded series of forty six different colors, three different translucencies, and two different aesthetic effects (single and multilayer).
The different colors are originated from the different constituent of color additive (such as Fe2O3,
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Er2O3); the different translucencies are originated from small difference in the amount of Y2 O3, and the different aesthetic effects are originated from the different padding method used in the process of dry pressing. These differences do not raise any concerns in the subject device, and this is demonstrated by biocompatibility testing.
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, pre-sintered density, sintered density, and flexural strength of the subject device are very similar to the predicate device.
The following table shows similarities and differences of the biocompatibility between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993. Results met all relevant requirements in the test standards, and are comparable to the predicate device. Table 5.2: Comparison of Biocompatibility Testing
| Description | Subject Device | Predicate Device (K093560) |
|---|---|---|
| Cytotoxicity | ||
| (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa | ||
| Irritation | ||
| (ISO 10993-10: 2010) | Not a primary oral mucosa irritant | |
| under the conditions of the study | No intracutaneous reactivity | |
| Sensitization (ISO | ||
| 10993-10: 2010) | Not a sensitizer under the | |
| conditions of the study | Not a sensitizer under the | |
| conditions of the study | ||
| Subacute and | ||
| Subchronic Toxicity | ||
| (ISO 10993-11: 2006) | No subchronic toxic effects observed | No subchronic toxic effects observed |
| Genotoxicity (ISO | ||
| 10993-3: 2003) | No genotoxic effects observed | N/A |
Therefore, "Dental Zirconia Blank for Aesthetic Restoration" manufactured by "Liaoning Upcera Co., Ltd." meet requirements per ISO 6872 and ISO 10993-1. Its performance meets the requirements of its pre-defined acceptance criteria and intended uses. The test results are also comparable to the predicate device.
Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "Dental Zirconia Blank for Aesthetic Restoration" and its predicate device have equivalent indications for use, similar material
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composition and biocompatibility, similar manufacturing process, and similar performance.
The differences between the "Dental Zirconia Blank for Aesthetic Restoration" and their predicate device do not raise any question regarding its equivalence.
"Dental Zirconia Blank for Aesthetic Restoration", as designed and manufactured, is equivalent to its predicate device, and therefore is substantially equivalent to its predicate device.