(118 days)
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
Upcera Dental Zirconia Blanks are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + Al2O3 with its composition conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry: Ceramic Materials.
Upcera Dental Zirconia Pre-Shaded Blanks are derived from the same Zirconia powder as the regular Upcera Dental Zirconia Blanks, with the addition of very small amount of inorganic pigments, before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the pre-shaded dental zirconia blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials.
The document describes the submission of a 510(k) premarket notification for "Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The primary goal of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K093560, "Upcera Zirconia Blanks"). The acceptance criteria and the study used to demonstrate that the device meets these criteria are primarily based on international standards for dental materials.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the specified ISO standards, and the reported performance indicates compliance with these standards.
| Test / Performance Metric | Acceptance Criteria (from Standards) | Reported Device Performance (Upcera Dental Zirconia Blank & Pre-Shaded Blank) |
|---|---|---|
| Mechanical Properties | ||
| Flexural Strength | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific values not provided in document, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Radioactivity | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific limits not provided, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Pre-sintered Density | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific values not provided, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Sintered Density | Conforms to ISO 6872:2008, Dentistry: Ceramic Materials (Specific values not provided, but compliance stated) | "Very similar to the predicate device," met all relevant requirements in test standard. |
| Biocompatibility | ||
| Cytotoxicity | Conforms to ISO 10993-5:2009 (No cytotoxicity effect) | No cytotoxicity effect |
| Irritation (Oral Mucosa) | Conforms to ISO 10993-10:2010 (Not a primary oral mucosa irritant) | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization | Conforms to ISO 10993-10:2010 (Not a sensitizer) | Not a sensitizer under the conditions of the study |
| Subacute/Subchronic Toxicity | Conforms to ISO 10993-11:2006 (No subacute and subchronic toxic effects) | No subacute and subchronic toxic effects observed |
| Genotoxicity | Conforms to ISO 10993-3:2003 (No genotoxic effects) | No genotoxic effects observed |
| Composition | Conforms to ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP) (Specific composition requirements for ZrO2, Y2O3, HfO2, Al2O3) | Regular: ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 99.0%Pre-Shaded: ZrO2 + Y2O3 + HfO2 + Al2O3 ≥ 98.0% + Inorganic pigments (Fe2O3, Pr2O3, and Er2O3, <2.0%) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "Bench testing was performed per ISO 6872:2008 and internal procedures" and "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used," as well as "Tests were conducted following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993." These standards typically specify sample sizes for their respective tests, but the specific number of samples tested for this submission is not detailed.
- Data Provenance: The studies were conducted by the manufacturer, Liaoning Upcera Company Limited, based in China (Liaoning Upcera Co., Ltd, No.122 Xianghuai Road, Economic Development Zone, Benxi, Liaoning, China). The data appears to be prospective as it was generated specifically for this 510(k) submission to demonstrate the device's properties.
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. This submission concerns material properties and biocompatibility as per international standards, not the interpretation of medical images or diagnostic outputs where expert consensus would typically be required for ground truth. The "ground truth" here is defined by meeting predefined technical specifications and safety profiles established by ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the "ground truth" is based on objective measurements against ISO standards. There is no mention of human-based adjudication for these types of material tests.
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
This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This submission is for a dental material (zirconia blanks) and does not involve AI or human interpretation in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for both mechanical properties and biocompatibility is defined by international consensus standards:
- For mechanical properties (flexural strength, radioactivity, density), the ground truth is established by the requirements and test methods outlined in ISO 6872:2008, Dentistry: Ceramic Materials.
- For biocompatibility, the ground truth is established by the requirements and test methods outlined in ISO 10993 series (specifically ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, ISO 10993-3:2003).
- For material composition, the ground truth is established by ISO 13356, Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).
8. The Sample Size for the Training Set
This information is not applicable and not provided. "Training set" is a concept typically associated with machine learning or AI models. This device is a physical material, and its performance is evaluated through direct testing against established material standards, not through training a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with its wings outstretched. The image is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October, 22, 2014
Liaoning Upcera Company Limited C/O Mr. Charles Shen Manton Business and Technology Services 853 Dorchester LN, Unit-B New Milford, NJ 07646
Re: K141724
Trade/Device Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 24, 2014 Received: July 24, 2014
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.
{1}------------------------------------------------
Page 2 - Mr. Shen
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Susan Runno DDS, MA
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
{2}------------------------------------------------
Section 4: Indication for Use
Section 4: Indications for Use
510(k) Number (if known): N/A K141724
Device Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Indications for Use:
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
、MACANNEW OF CREATH CHANNER 2007年 アイズル アイデリア アイデリア コミュニア ( PERMIC 2007)
Section 4: Indication for Use
Sec. 4 Page 1 of 1
{3}------------------------------------------------
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
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
Charles Shen Manton Business and Technology Services 853 Dorchester LN, Unit-B New Milford, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: June 19, 2014 5.3
5.4 Device Name:
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Proprietary Name: Shaded Blank Dental Zirconia Ceramics Common Name: Classification Name: Powder, Porcelain Device Classification: II 21 CFR 872.6660 Regulation Number: Dental Panel: General EIH Product Code:
Predicate Device Information: ર્ડ
- K093560, "Upcera Zirconia Blanks", manufactured by "Shenyang Upcera Co., (1) Ltd.''
Device Description: ર્સ્વર્સ
Upcera Dental Zirconia Blanks are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + Al2O3 with its composition conforms to ISO 13356,
{4}------------------------------------------------
Section 5: 510(k) Summary
Implants for Surgery -- Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry: Ceramic Materials
Upcera Dental Zirconia Pre-Shaded Blanks are derived from the same Zirconia powder as the regular Upcera Dental Zirconia Blanks, with the addition of very small amount of inorganic pigments, before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the pre-shaded dental zirconia blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials
5.7 Intended Use:
Upcera Dental Zirconia Blanks & Dental Zirconia Pre-Shaded Blanks are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
5.8 Summary of Device Testing:
Bench testing was performed per ISO 6872:2008 and internal procedures to ensure that the Upcera Dental Zirconia Blanks & Dental Zirconia Pre-Shaded Blanks met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
ર.9 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device | Predicate Device (K093560) |
|---|---|---|
| Indication forUse | Upcera Dental Zirconia Blanks & DentalZirconia Pre-Shaded Blanks are used fordental restorations using differentCAD/CAM or manual milling machines.All blanks are processed thought dentallaboratories or by dental professionals. | Upcera Zirconia Blanks are indicatedfor dental restorations using differentCAD/CAM or manual millingmachines. All blanks are processedthought dental laboratories or bydental professionals. |
| Basic Design | Blocks, disc, and rod | Blocks, disc, and rod |
| Materials | Regular:Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 $\ge$99.0%) | Zirconia (ZrO2 + Y2O3 + HfO2 +Al2O3 $\ge$ 99.0%) |
Table 5.1: Comparison of Intended Use. Design. Material, and Processing
{5}------------------------------------------------
| Pre-Shaded:Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥98.0%)Inorganic pigments (Fe2O3, Pr2O3, andEr2O3, <2.0%) | ||
|---|---|---|
| Processing | Sintering at temperature > 1500 °C | Sintering at temperature > 1500 °C |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Color | None, and Pre-shaded ( for pre-shadedseries) | None |
| Sterile | Non-sterile | Non-sterile |
Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. The only minor difference is that the predicate device has no color, while our devices in submission have both the non-color regular series and pre-shaded series of twenty one different colors. The colors are originated from inorganic pigments of Fe2O3, Pr2O3, and Er203, that are of very small amount (< 2.0%), and does not raise any safety issues, demonstrated by biocompatibity study.
5.10 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, and results met all relevant requirements in the test standards, and are comparable to the predicate device.
Table 5.2: Comparison of Biocompatibility Testing
| Description | Our Devicea | Predicate Device (K093560) |
|---|---|---|
| Cytotoxicity(ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa | Not a primary oral mucosa | No intracutaneous reactivity |
{6}------------------------------------------------
Section 5: 510(k) Summary
| Irritation(ISO 10993-10: 2010) | irritant under the conditions ofthe study | |
|---|---|---|
| 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 subacute and subchronictoxic effects observed | No acute toxicity |
| Genotoxicity (ISO10993-3: 2003) | No genotoxic effects observed | N/A |
4: Performed on pre-shaded zirconia blanks to cover both the regular and pre-shaded zirconia blanks.
Therefore, Upcera Dental Zirconia Blanks & Dental Zirconia Pre-Shaded Blanks manufactured by "Liaoning Upcera Co., Ltd." meet requirements per ISO 6872 and ISO 10993-1. It is safe and effective, and its performance meets the requirements of its predefined acceptance criteria and intended uses. The test results are also comparable to the predicate device.
5.11 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and similar performance.
The difference between the Upcera Dental Zirconia Blanks & Dental Zirconia Pre-Shaded Blanks and their predicate device do not raise any question regarding its safety and effectiveness.
Upcera Dental Zirconia Blanks & Dental Zirconia Pre-Shaded Blanks, as designed and manufactured, are as safe and effective as its predicate device, and therefore is substantially equivalent as 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.