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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the CopranColor device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a Class II medical device (dental porcelain powder). For such devices, acceptance criteria are typically related to material properties, biocompatibility, and functional equivalence to a predicate device, rather than diagnostic accuracy metrics common for AI/ML devices.

Acceptance Criteria (Inferred from documentation)	Reported Device Performance
Material Specifications: Ensuring CopranColor meets unspecified internal specifications related to its use as a coloring agent for zirconia dental restorations.	"All tests were verified to meet acceptance criteria." (Specific details of these criteria or test results are not provided).
Biocompatibility: Confirmation that the materials used in CopranColor are safe for use in dental restorations.	"Biocompatibility testing was performed to verify the equivalent safety of the materials that are used." The document also states, "The materials used in the new devices are all biocompatible as the predicate device."
No Negative Effect on Physical Material Properties: The coloring liquid should not adversely affect the physical properties of the zirconia blanks it colors.	"The colouring liquid has no negative effect to the physical material properties." (No specific test results quantifying this are provided, but this is explicitly stated).
Substantial Equivalence: Demonstrated equivalence to predicate device (ZENOTEC Zr / ZENOSTAR Color Zr) in terms of intended use, operating principles, technology, and manufacturing process.	The document concludes that "CopranColor in combination with the zirkonia blanks has the same technological characteristics as the predicate device ZENOTEC Zr / ZENOSTAR Color Zr" and "we conclude the device is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The document mentions "Bench testing was performed to ensure that the CopranColor met its specifications" and "Biocompatibility testing was performed." However, no numbers regarding the quantity of samples (e.g., number of colored zirconia blanks, number of biocompatibility test samples) are provided.
Data Provenance: Not explicitly stated. It's safe to assume the testing was conducted internally by White Peaks Dental Systems GmbH & Co. KG or by a contracted lab, likely in Germany given the company's address. The document does not specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a coloring agent for dental materials, not a diagnostic AI/ML device requiring expert ground truth for interpretation. Therefore, this information is not applicable and not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as this is a material science device, not an AI/ML diagnostic interpretation system.

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:

Not applicable. This is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the material and biocompatibility testing, the "ground truth" would be established through pre-defined material specifications and standards (e.g., ISO standards for dental materials) and validated biocompatibility testing protocols. This is intrinsic to material science and regulatory compliance for such devices, rather than a "ground truth" derived from expert consensus or pathology data as seen in diagnostic tools.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The development of the coloring agent would involve chemical formulation and iterative testing, but not in the sense of an "AI training set."

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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K123680

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.

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Indications for Use

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.

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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

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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_

Prescription Use X (Part 21 CFR 801 Subpart D)

.. .

. "

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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)

Page 1 of 1

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

Regulation Number and Section

§ 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.