(122 days)
"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.
"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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Dental Zirconia Blank for Aesthetic Restoration":
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are largely based on adherence to existing ISO standards for dental ceramic materials and biocompatibility.
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Conformance to ISO 6872:2008 (Dentistry, Ceramic Materials) | "All tests were verified to meet acceptance criteria." |
| "Radioactivity" comparability | "very similar to the predicate device." | |
| "Pre-sintered density" comparability | "very similar to the predicate device." | |
| "Sintered density" comparability | "very similar to the predicate device." | |
| "Flexural strength" comparability | "very similar to the predicate device." | |
| Biocompatibility | Conformance to ISO 10993 (various parts) | "Results met all relevant requirements in the test standards, and are comparable to the predicate device." |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | "No cytotoxicity effect" |
| Irritation Oral Mucosa (ISO 10993-10:2010) | Not a primary oral mucosa irritant | "Not a primary oral mucosa irritant under the conditions of the study" |
| Sensitization (ISO 10993-10:2010) | Not a sensitizer | "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 | "No genotoxic effects observed" |
| Overall Performance | Meets requirements per ISO 6872 and ISO 10993-1 | "Its performance meets the requirements of its pre-defined acceptance criteria and intended uses." |
| Comparable to predicate device | "The test results are also comparable to the predicate device." |
2. Sample Sizes used for the test set and the data provenance:
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many specimens for flexural strength, how many animals for biocompatibility tests). It refers to "Bench testing" performed "per ISO 6872:2008 and internal procedures" and "Biocompatibility testing" performed "following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993." These ISO standards typically specify minimum sample sizes for material testing.
- Data Provenance: The studies were conducted by Liaoning Upcera Co., Ltd. for their "Dental Zirconia Blank for Aesthetic Restoration." The country of origin for the studies is implicitly China, as the submitter is based in Benxi, Liaoning, China. The studies are prospective in the sense that they were performed on the subject device to demonstrate compliance with standards and equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based material characterization and biocompatibility assessments, not subjective evaluations requiring expert consensus for ground truth. The "ground truth" here is adherence to established international standards (ISO).
4. Adjudication method for the test set:
Not applicable. The tests are scientific measurements and biological evaluations, not requiring human adjudication.
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 a material science and biocompatibility study for a dental restorative material, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a material science and biocompatibility study, not an algorithm.
7. The type of ground truth used:
The "ground truth" used for this device's acceptance is based on:
- International Standards: Primarily ISO 6872:2008 for ceramic materials and ISO 10993 series for biological evaluation of medical devices.
- Predicate Device Performance: The device's performance is explicitly compared against a legally marketed predicate device (K093560, "Upcera Zirconia Blanks") to establish substantial equivalence.
8. The sample size for the training set:
Not applicable. There is no machine learning or AI component described in this device submission, so the concept of a "training set" is irrelevant.
9. How the ground truth for the training set was established:
Not applicable, as no training set is involved.
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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 +
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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 forUse | "Dental Zirconia Blank for Aesthetic Restoration" ismainly used in prosthetic treatment. When theflexural strength of Dental Zirconia Blank forAesthetic Restoration after sintering is between 300-500 MPa, the product can be used for veneering,inlay, single crown, and substructure ceramic forthree-unit prostheses not involving molarrestoration; when the flexural strength of DentalZirconia Blank for Aesthetic Restoration aftersintering is over 500 MPa, it can be used forveneering, inlay, single crown, and substrateceramic for three-unit prostheses. All blanks areprocessed through dental laboratories or by dentalprofessionals. | Upcera Zirconia Blanks are indicated fordental restorations using differentCAD/CAM or manual milling machines.All blanks are processed through dentallaboratories 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 twodifferent 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 MucosaIrritation(ISO 10993-10: 2010) | Not a primary oral mucosa irritantunder the conditions of the study | No intracutaneous reactivity |
| Sensitization (ISO10993-10: 2010) | Not a sensitizer under theconditions of the study | Not a sensitizer under theconditions of the study |
| Subacute andSubchronic Toxicity(ISO 10993-11: 2006) | No subchronic toxic effects observed | No subchronic toxic effects observed |
| Genotoxicity (ISO10993-3: 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.
§ 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.