(118 days)
Not Found
No
The 510(k) summary describes a material (zirconia blanks) used for dental restorations and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a raw material (blanks) used for creating dental restorations like crowns and bridges, which replace missing or damaged teeth. While these restorations can improve function and aesthetics, the blanks themselves are not considered therapeutic as they do not directly treat a disease or medical condition.
No
The device is described as a material (zirconia blanks) used for creating dental restorations, not for diagnosing any medical condition or disease.
No
The device description clearly states that the device is a physical product made from Zirconia powder, processed into blanks for 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 for creating dental restorations (crowns, bridges, veneers, inlay/onlay) using CAD/CAM or manual milling machines. This is a manufacturing process for a medical device that will be implanted or used in the mouth.
- Device Description: The description details the composition and properties of the zirconia blanks used to fabricate these restorations. It focuses on the material itself and its suitability for dental applications.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to obtain information about a physiological state. IVDs are typically used to test samples from the human body (like blood, urine, tissue) to provide diagnostic information.
- User and Setting: The intended users are dental laboratories and dental professionals, who are involved in the fabrication and placement of dental restorations, not in diagnostic testing.
In summary, this device is a material used in the manufacturing of dental prosthetics, which are medical devices, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
EIH
Device Description
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
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
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.
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.
Biocompatibility testing: 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.
Cytotoxicity (ISO 10993-5:2009): No cytotoxicity effect
Irritation Oral Mucosa Irritation (ISO 10993-10: 2010): Not a primary oral mucosa irritant under the conditions of the study
Sensitization (ISO 10993-10: 2010): Not a sensitizer under the conditions of the study
Subacute and Subchronic Toxicity (ISO 10993-11: 2006): No subacute and subchronic toxic effects observed
Genotoxicity (ISO 10993-3: 2003): No genotoxic effects observed
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
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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
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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,
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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 for | ||
| 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. | Upcera Zirconia Blanks are indicated | |
| for dental restorations using different | ||
| CAD/CAM or manual milling | ||
| machines. All blanks are processed | ||
| thought dental laboratories or by | ||
| dental 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
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| | Pre-Shaded:
Zirconia (ZrO2 + Y2O3 + HfO2 + Al2O3 ≥
98.0%)
Inorganic pigments (Fe2O3, Pr2O3, and
Er2O3, 1500 °C | Sintering at temperature > 1500 °C |
| Dimension | Various | Various |
| Single Use | Yes | Yes |
| Color | None, and Pre-shaded ( for pre-shaded
series) | 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 (