(83 days)
ZENOTEC Zr / ZENOSTAR Color Zr
Not Found
No
The 510(k) summary describes a coloring agent for dental restorations and does not mention any AI or ML components or functionalities.
No.
CopranColor is a coloring agent for dental materials, not a device used for diagnosis, treatment, or prevention of disease.
No
Explanation: The device is described as a coloring agent for zirconia ceramic materials used in dental restorations. Its purpose is to color the restorations, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states that CopranColor is a "coloring agent" and is used "together with the zirconium dioxide blanks". This indicates a physical substance, not software.
Based on the provided information, CopranColor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that CopranColor is a "coloring agent for the shading of white zirconia ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients." This describes a material used in the fabrication of a medical device (dental restoration), not a device used to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description reinforces this, stating it's an "accessory to zirkonium dioxide dental restaurations" used by dental technicians for fabrication.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Performing tests on patient specimens
CopranColor is a material used in the manufacturing process of a dental restoration, which is a medical device. It is not a diagnostic tool.
N/A
Intended Use / Indications for Use
CopranColor is intended to be used as the coloring agent for the shading of white zirconia ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients.
Product codes
EIH
Device Description
CopranColor is a device that may be used as an accessory to zirkonium dioxide dental restaurations such as Copran ZR /Origin YZ.
Together with the zirconium dioxide blanks the CopranColor can be used by professional dental technicians for fabrication of all.ceramic restorations.
The CopranColor is a liquid including colorants that is used 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.
The colouring liquid has no negative effect to the physical material properties.
This includes the variants:
- O Copran Color (used for white Ziconium)
- Copran Ultra-T Color ( used for ceramic blending) 0
- Copran Monolith Color (used for milled teeth) o
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
Not Found
Summary of Performance Studies
Bench testing was performed to ensure that the CopranColor 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.
Key Metrics
Not Found
Predicate Device(s)
ZENOTEC Zr / ZENOSTAR Color Zr
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
FEB 2 1 2013
510(k) Summary
| owner's name: | White Peaks Dental Systems GmbH & Co. KG |
|---|---|
| address: | Langeheide 9 |
| 45239 Essen | |
| Germany | |
| Establishment registration no.: | 3009409473 |
| Contact person: | Oliver Puckert |
| Phone / Fax: | +49-281-206458-0 / +49-281-206458-13 |
| Name of the device: | CopranColor |
| Trade or proprietary name: | CopranColor |
| Classification name: | Powder, Porcelain |
| Device classification: | 2 |
| Regulation / Product code: | 21 CFR 872.6660 / EIH |
Predicate device equivalence:
CopranColor equals the predicate device with respect to the indications for use and the fundamental technology, relating to the use of Zirkonium dioxide blanks, the application process (CAD/CAM technology), the biocompatibility, coloring system and other technical aspects.
Device Descripton
CopranColor is a device that may be used as an accessory to zirkonium dioxide dental restaurations such as Copran ZR /Origin YZ.
Together with the zirconium dioxide blanks the CopranColor can be used by professional dental technicians for fabrication of all.ceramic restorations.
1
Indications for Use
CopranColor is intended to be used as the coloring agent for the shading of white zirconia ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients.
Comparison of Technology Characteristics
The CopranColor is a liquid including colorants that is used 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.
The colouring liquid has no negative effect to the physical material properties.
This includes the variants:
- O Copran Color (used for white Ziconium)
- Copran Ultra-T Color ( used for ceramic blending) 0
- Copran Monolith Color (used for milled teeth) o
Determination of Substantial Equivalence
CopranColor in combination with the zirkonia blanks has the same technological characteristics as the predicate device ZENOTEC Zr / ZENOSTAR Color Zr.
The new device has the following similarities to the previously cleared predicate device:
- Same intended use
- -Same operating principles
- -Same technology
- Same manufacturing process ー
The materials used in the new devices are all biocompatible as the predicate device.
Conclusion drawn from nonclinical / clinical test:
Based on the above and the fact that main component CopranZR is cleared for the US market since 2009 we consider the device CopranColor being safe and effective and we conclude the device is substantially equivalent to the predicate device: .ZENOTEC Zr / ZENOSTAR Color Zr.
2
Summary of Device Testing:
Bench testing was performed to ensure that the CopranColor 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.
Section - Page / of | 5 - 4/ 5 vision
Date | 2013-02-15 Revision
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2013
Mr. Oliver Puckert CEO White Peakes Dental Systems GmbH & Co. KG Langeheide 9 45239 Essen GERMANY
Re: K123680
Trade/Device Name: CopranColor Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 13, 2012 Received: November 30, 2012
Dear Mr. Puckert:
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. Iisting 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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Page 2 - Mr. Puckert
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runner, DDSMA
Mary S. Runner
2013.02.21
12:03:50 -05'00'
FOR
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
04- Indications for Use statement White Peaks Dental Systems GmbH & Co. KG - CopranColor
Indications for Use
2123680 510(k) Number (if known):
Device Name: CopranColor_
CopranColor is intended to be used as the coloring agent for the shading of white zirconia ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients.
Prescription Use X (Part 21 CFR 801 Subpart D)
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Over-The-Counter Use AND/OR (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)
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| Mary S. Runner | |
|---|---|
| Susan Runner, DDS, MA | 2013.02.21 09:56:39 |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K123680 |
|---|---|
| ---------------- | --------- |
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2013-01-24 Section - Page / of | Revision Date