(118 days)
No
The device description and performance studies focus on the chemical composition and biocompatibility of coloring liquids for dental zirconia, with no mention of AI or ML technologies.
No
This device is a coloring liquid used for dental zirconia frameworks and restorations to match natural tooth color, not for therapeutic purposes.
No
The device is a coloring liquid used for aesthetic purposes (to adjust the restoration to match the natural color of the patient's teeth) and does not perform any diagnostic function.
No
The device is a liquid used for coloring dental zirconia, which is a physical substance, 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 the coloration of dental zirconia substructures and anatomy before sintering. This is a process performed on a material that will be used to create a dental restoration, not a test performed on a biological sample from a patient to diagnose a condition.
- Device Description: The description clearly states it's a liquid used for staining dental zirconia frameworks and restorations. It's a material used in the manufacturing process of a dental device.
- No Biological Sample Testing: There is no mention of the device being used to test or analyze any biological sample (blood, urine, tissue, etc.) from a patient.
- Focus on Material Properties: The performance studies and key metrics focus on the properties of the coloring liquid itself and its biocompatibility, not on its ability to detect or measure a substance in a biological sample.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.
Product codes
EIH
Device Description
Upcera Coloring Liquid (I and II) are water based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth.
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
professional dental technicians
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
Bench testing was performed to ensure that the Upcera Coloring Liquid (I and II) 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to ensure that the Upcera Coloring Liquid (I and II) 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. Tests were conducted following the recommended procedures outlined in USP or ISO 10993-1, and results met all relevant requirements in the test standards, and are comparable to the predicate device.
Heavy Metals (USP)
Cytotoxicity (ISO 10993-5:2009): No cyteotoxicity 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Heavy Metals (USP): Pb
§ 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The logo is rendered in 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: K141723
Trade/Device Name: Upcera Coloring Liquid (I and II) 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 Runyon 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 K141723
Device Name: Upcera Coloring Liquid (I and II)
Indications for Use:
Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.
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)
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
5.1 Submitter & Foreign Manufacture Identification
Liaoning Upcera Co., Ltd No.122 Xianghuai Road, Economic Development Zone, Benxi, Liaoning, China Tel: (086) 24-5565055 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
5.3 Date of Summary: May 15, 2014
| 5.4
| Device Name: | |
|---|---|
| Proprietary Name: | Upcera Coloring Liquid (I and II) |
| Common Name: | Coloring Liquid |
| Classification Name: | Powder, Porcelain |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.6660 |
| Panel: General | Dental |
| Product Code: | EIH |
ર્ડ Predicate Device Information:
K123680, "CopranClor", manufactured by "White Peaks Dental Systems Gmbh (1) & Co. KG." located in Essen, Germany
ર્સ્વર્સ Device Description:
Upcera Coloring Liquid (I and II) are water based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth.
4
Upcera Coloring Liquid I is provided in 21 different shades, and Upcera Coloring Liquid II is provided in 16 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures.
5.7 Intended Use:
Upcera Coloring Liquid (I and II) is a liquid used for the complete or partial coloration of milled Upcera zirconia substructure and anatomy before sintering.
5.8 Summary of Device Testing:
Bench testing was performed to ensure that the Upcera Coloring Liquid (I and II) 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.
રું. કે Substantial Equivalence Discussion
Upcera Coloring Liquid (I and II) is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- K123680, "CopranClor", manufactured by "White Peaks Dental Systems Gmbh (1) & Co. KG." located in Essen, Germany
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device (Upcera Coloring Liquid I and
II) | Predicate Device (K123680) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | Upcera Coloring Liquid (I and II) is a
liquid used for the complete or partial
coloration of milled Upcera zirconia
substructure and anatomy before
sintering. | CopranColor is intended to be used as
the coloring agent for the shading of
white zirconia ceramic materials that
are to be used by professional dental
technicians to fabricate all-ceramic
dental restorations for dental patients. |
| Technology | Water based with inorganic pigments | Water based with inorganic pigments |
| Operating
Principle | Brush or immerse zirconia ceramic
materials with coloring liquid before
sintering | Brush or immerse with zirconia
ceramic material before sintering |
| Ingredient | Upcera Coloring Liquid I:
Water, Polyethylene glycol, HCl | Water, Polyethylene glycol, inorganic
salts |
Table 5.1: Comparison of Intended Use, Design, Material, and Processing
5
Section 5: 510k Summary
| | inorganic salts
Upcera Coloring Liquid II:
Water, Polydextrose, inorganic salts | |
|--------------|---------------------------------------------------------------------------------------|-------------|
| Bottle Size | Various | Various |
| Shade | Various | Various |
| Prescription | Yes | Yes |
| Sterile | Non-sterile | Non-sterile |
Our device is similar to the predicate device in terms of indications for use, technology, and principle of operation. It is similar with predicate device that water and inorganic pigments are the main ingredients.
The indication for use of the subject device is phrased differently than the predicate device for business reasons. However, both share exactly the same expected use: as coloring agent for shading of dental zirconia blanks. Same as predicate device, the subject device is also restricted to professional dental technicians, as illustrated on its product label.
There are some minor differences between Upcera Coloring Liquid I and the predicate device. First, the predicate device does not contain acid (HCl). HCl will be evaporated with no residue left at the sintering step after the coloring liquid is applied to the zirconia ceramics, so it will not cause any effect to the patients. Second, Upcera Coloring Liquid I uses different inorganic pigments (metal nitrates). This will not raise any safety issues as the metal nitrates we use all have long established safety profiles, and we have conducted biocompatibility testing with the products.
There are minor differences between Upcera Coloring Liquid II and the predicate device. First, the predicate device does not contain Polydextrose. Polydextrose is an indigestible synthetic polymer of glucose. It is a food ingredient classified as soluble fiber by the U.S. Food and Drug Administration, so it will not cause any effect to the patients. Second, Upcera Coloring Liquid II uses different inorganic pigments (metal nitrates). This will not raise any safety issues as the metal nitrates we use all have long established safety profiles, and we have conducted biocompatibility testing with the products.
The following table shows similarities and differences of the key performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in USP or ISO 10993-1, and results met all relevant requirements in the test standards, and are comparable to the predicate device.
6
Section 5: 510k Summary
| Description | Our Device (Upcera Coloring Liquid I and II) | Predicate Device (K123680) |
|---|---|---|
| Heavy Metals (USP) | $Pb \le 10mg/kg$ , $Cd \le$ | |
| $3mg/kg$ , $Hg \le 2mg/kg$ , As | ||
| $\le 2mg/kg$ , $Cr \le 2mg/kg$ | Information not available | |
| Cytotoxicity | ||
| (ISO 10993-5:2009) | No cyteotoxicity 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 | Claims biocompatible in | |
| general | ||
| Subacute and | ||
| Subchronic Toxicity | ||
| (ISO 10993-11: 2006) | No subacute and subchronic | |
| toxic effects observed | ||
| Genotoxicity (ISO | ||
| 10993-3: 2003) | No genotoxic effects observed |
| Table 5.2: Comparison of Performance Testing | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
Therefore, the Upcera Coloring Liquid (I and II) manufactured by "Liaoning Upcera Co., Ltd." meet requirements per internal standard, USP, ISO 10993-1. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. The test results are also comparable to the predicate device.
5.10 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that Upcera Coloring Liquid (I and II) and its predicate devices have the similar indications for use, technology, principle of operation, similar composition, performance, and biocompatibility.
The difference between Upcera Coloring Liquid (I and II) and its predicate device do not raise any question regarding its safety and effectiveness.
Upcera Coloring Liquid (I and II), as designed and manufactured, are as safe and effective as its predicate device, and therefore are substantially equivalent as its predicate device.