(123 days)
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No
The 510(k) summary describes a dental veneering material (porcelain powder, paste, and liquid) used for color staining and glazing. The description focuses on the material composition, physical properties, and intended use in prosthetic dentistry. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies described are bench testing and biocompatibility testing, which are standard for material-based devices.
No
This device is a dental veneering material used for aesthetic purposes (color staining and glazing) of dental restorations, not for treating diseases or conditions.
No
Explanation: The device is described as a "dental veneering material" used for color staining and glazing of dental restorations, which is a prosthetic (restorative) function, not a diagnostic one. Its intended use is to form a porcelain veneer and make artificial teeth "more similar with natural teeth."
No
The device is a physical material (powder, paste, and liquid) used in prosthetic dentistry, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "veneering material for fixed prosthesis in crowns and bridges" and is used in "prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure." This describes a material used on a dental prosthesis, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description details the composition and form of a dental material used for staining and glazing restorations. It does not mention any interaction with biological samples or the detection of any analytes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Detection of analytes (biomarkers, pathogens, etc.)
- Use in a laboratory or clinical setting for diagnostic purposes
The device is a dental material used in the fabrication and finishing of dental prosthetics.
N/A
Intended Use / Indications for Use
"Glaze Paste, Glaze Powder, and Glaze Liquid" are indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
"Glaze Paste, Glaze Powder, and Glaze Liquid" is a dental veneering material used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar with natural teeth.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are actually three products: Powder, paste, and liquid. "Glaze Powder" is in the form of a porcelain dry powder and liquid. When mixed together by the technician at a dental lab, they form the paste stain before applied to the patient.
"Glaze Paste" is pre-mixed paste from porcelain powder and liquid, which can help dental technicians save the mixing process.
The porcelain powder is composed primarily of SiO2, with minor components of Al2O3, K20, Na2O, Li2O, and color additives. The liquid is composed of deionized water and organic solvents. The liquid can also be used as a thinner to control viscosity of paste.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are supplied in seventy one different colors, with or without fluorescence effect.
The performance of material conforms to ISO 6872, Dentistry, Ceramic Materials.
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
Used in prosthetic dentistry by a dental technician at a dental lab.
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 6872:2015 and internal procedures to ensure that the "Glaze Paste, Glaze Powder, and Glaze Liquid" 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.
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, transition temperature, thermal expansion, and flexural strength of the subject device are very similar to the predicate device.
Biocompatibility 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.
Key results from biocompatibility testing include:
- 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.
- Acute Toxicity (ISO 10993-11: 2006): No acute toxic effects observed.
- 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 (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/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Liaoning Upcera Co., Ltd % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland. New Jersey 07436
September 2,2018
Re: K181167
Trade/Device Name: Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: June 2, 2018 Received: June 5, 2018
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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting 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) K181167
Device Name
Glaze Paste, Glaze Powder, and Glaze Liquid
Indications for Use (Describe)
"Glaze Paste, Glaze Powder, and Glaze Liquid" are indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
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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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 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: June 5, 2018
| 5.4
| Device Name: | |
|---|---|
| Proprietary Name: | Glaze Paste, Glaze Powder, and Glaze Liquid |
| Common Name: | Dental Ceramics |
| Classification Name: | Porcelain powder for clinical use |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: | Dental |
| Product Code: | EIH |
ર્સ્ટ Predicate Device Information:
(1) K151731, "rainbow Paste Stain", manufactured by "GENOSS Co., Ltd."
Device Description: ર્સ્વ
"Glaze Paste, Glaze Powder, and Glaze Liquid" is a dental veneering material used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make the artificial teeth (dental prosthesis) more similar with natural teeth.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are actually three products: Powder, paste, and liquid. "Glaze Powder" is in the form of a porcelain dry powder and liquid.
4
Section 5: 510(k) Summary
When mixed together by the technician at a dental lab, they form the paste stain before applied to the patient.
"Glaze Paste" is pre-mixed paste from porcelain powder and liquid, which can help dental technicians save the mixing process.
The porcelain powder is composed primarily of SiO2, with minor components of Al2O3, K20, Na2O, Li2O, and color additives. The liquid is composed of deionized water and organic solvents. The liquid can also be used as a thinner to control viscosity of paste.
"Glaze Paste, Glaze Powder, and Glaze Liquid" are supplied in seventy one different colors, with or without fluorescence effect.
The performance of material conforms to ISO 6872, Dentistry, Ceramic Materials.
5.7 Indications for Use:
"Glaze Paste, Glaze Powder, and Glaze Liquid" are indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
5.8 Summary of Device Testing:
Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the "Glaze Paste, Glaze Powder, and Glaze Liquid" 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.
5.9 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
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| Description | Subject Device | Predicate Device (K151731) |
|---|---|---|
| Indication for | ||
| Use | "Glaze Paste, Glaze Powder, and Glaze | |
| Liquid" are indicated for use as a veneering | ||
| material for fixed prosthesis in crowns and | ||
| bridges. This device is used in prosthetic | ||
| dentistry by forming a porcelain veneer on to | ||
| a ceramic substructure. | rainbow Paste Stain is indicated for use as | |
| a veneering material for fixed prosthesis | ||
| in crowns and bridges. This device is used | ||
| in prosthetic dentistry by forming a | ||
| porcelain veneer on to a ceramic | ||
| substructure. | ||
| Form | Paste, liquid, and powder | Paste |
| Materials | SiO2, Al2O3, K2O, Na2O, Li2O, etc | Feldspar, SiO2, Na2CO3, K2CO3, Li2CO3, |
| CaCO3, ZnO, etc. | ||
| Type, class of | ||
| dental ceramic | Type I - Class I | Type I - Class I |
| Use | Prescription | Prescription |
| Single Use | Yes | Yes |
| Feature | Various colors | Various colors |
| Sterile | Non-sterile | Non-sterile |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
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 minor differences do not raise any safety or efficacy concerns.
Comparison of Performance with Predicate Device 5.10
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, transition temperature, thermal expansion, 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.
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| Description | Subject Device | Predicate Device (K151731) |
|---|---|---|
| Cytotoxicity | ||
| (ISO 10993-5:2009) | No cyteotoxicity effect | No cyteotoxicity 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 | ||
| Acute Toxicity (ISO | ||
| 10993-11: 2006) | No acute toxic effects observed | No acute toxic effects |
| observed | ||
| Subacute and | ||
| Subchronic Toxicity | ||
| (ISO 10993-11: 2006) | No subacute and subchronic | |
| toxic effects observed | Not performed | |
| Genotoxicity (ISO | ||
| 10993-3: 2003) | No genotoxic effects observed | No genotoxic effects |
| observed |
Table 5.2: Comparison of Biocompatibility Testing
Therefore, "Glaze Paste, Glaze Powder, and Glaze Liquid" manufactured by "Liaoning Upcera Co., Ltd." meet requirements per ISO 6872 and ISO 10993-1. The test results are also comparable to the predicate device.
Substantial Equivalence Conclusion 5.11
It has been shown in this 510(k) submission that "Glaze Paste, Glaze Powder, and Glaze Liquid" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and similar performance.
The difference between the "Glaze Paste, Glaze Powder, and Glaze Liquid" and its predicate device do not raise any question regarding its equivalence.
"Glaze Paste, Glaze Powder, and Glaze Liquid", as designed and manufactured, is equivalent to its predicate device, and therefore is substantially equivalent as its predicate device.