IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.

AI/ML Overview

This document is a 510(k) summary for a dental product called IPS Ivocolor. It details the product's description, indications for use, comparison to predicate devices, and a conclusion of substantial equivalence. However, it does not describe a study that proves the device meets acceptance criteria in the way that an AI/ML device submission would.

The document discusses the physical properties and compatibility of the dental material itself, rather than the performance of a diagnostic algorithm. Therefore, the requested information categories (sample size, experts, adjudication, MRMC, standalone, etc.) are structured for AI/ML device studies and are not applicable to this type of traditional medical device submission.

I can extract the acceptance criteria (in terms of physical properties) and the reported device performance related to those criteria from the document, but it will not be presented in the context of an AI/ML study.

Here's the information that can be extracted, interpreted within the context of a traditional device submission (not AI/ML):

Acceptance Criteria and Reported Device Performance (as related to physical properties of dental materials)

Acceptance Criteria (from ISO 6872)	Reported Device Performance (IPS Ivocolor)
Uniformity	Meets requirements
Cleanliness	Meets requirements
Radioactivity of ceramic	Meets requirements
Color Coding	Meets requirements
Flexural Strength	Meets requirements
Coefficient of Linear Thermal Expansion (CTE)	Slightly lower than primary predicate, ensures compatibility with chosen ceramics
Glass Transition Temperature	Slightly lower than primary predicate, ensures compatibility with chosen ceramics
Chemical Solubility	Meets requirements

Study Details (Note: These categories are for AI/ML studies and are not directly applicable to this traditional dental material submission. The information below is an interpretation based on the document's content, if an analogy were to be forced.)

Sample size used for the test set and the data provenance: Not applicable. This device is a dental material, and the "test set" would be the physical samples tested according to ISO 6872. The document does not specify the number of samples. The provenance of the "data" (i.e., test results) would be from in-house laboratory testing by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For dental material properties, "ground truth" is established by standardized laboratory testing methods (e.g., ISO 6872), not by expert consensus on diagnostic images.
Adjudication method for the test set: Not applicable. Standardized lab tests have pass/fail criteria based on ISO standards.
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 diagnostic device nor a reader study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.
The type of ground truth used: Standardized physical property measurements according to ISO 6872.
The sample size for the training set: Not applicable. There is no training set for a material like this. Development would involve experimental formulation and testing.
How the ground truth for the training set was established: Not applicable.

Summary of the Document's "Study" Information (in its actual context):

The document describes material testing to demonstrate that IPS Ivocolor meets the requirements of ISO 6872 for ceramic materials. This is a standard for dental ceramic materials and specifies various physical properties and their acceptable ranges. The manufacturer performed tests on IPS Ivocolor for properties such as uniformity, cleanliness, radioactivity, color coding, flexural strength, coefficient of linear thermal expansion (CTE), glass transition temperature, and chemical solubility. The document states that the product "meets the requirements" for these tests. It also notes that the CTE and Glass transition temperature are "slightly lower than those of the primary predicate," which is presented as a design choice to ensure compatibility with a wider range of ceramics.

The primary "proof" of meeting acceptance criteria for this type of device is compliance with relevant international standards for dental materials (like ISO 6872) and demonstrating substantial equivalence to a legally marketed predicate device through comparative data (chemical composition, physical properties, indications for use, and operating principles).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

Ivoclar Vivadent AG c/o Ms. Donna Hartnett Director OA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228

Re: K151894

Trade/Device Name: IPS Ivocolor Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: September 18, 2015 Received: September 21, 2015

Dear Ms. Hartnett:

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.

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang -S". The signature is on the left side of the image and is a series of loops and lines. The name is on the right side of the image and is in a simple, sans-serif font. The name is stacked, with "Tina" on top and "Kiang -S" on the bottom.

for 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

Enclosure

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Indications for Use

510(k) Number (if known) K151894

Device Name IPS IVOCOLOR

Indications for Use (Describe)

Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental.

Veneering ceramics
Press ceramics
Milling ceramics
Zirconium oxide (frameworks and full-contour restorations)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMM Revised IPS Ivocolor

Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the words "passion vision innovation" written in smaller letters below. Above the company name are green and blue dots and squares. The logo is simple and modern, and it conveys a sense of professionalism and innovation.

Contact:	Donna Marie Hartnett
Company:	Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535
Date Prepared:	October 27, 2015
Proprietary Name:	IPS Ivocolor
Classification Name:	Powder, Porcelain CFR Regulation (872.6660)(Classification Code EIH)
Predicate Device:	IPS 99 One and IPS 99 Ceram (K121359) (primary)Eris Layering Materials (K012174) (reference only)

Device Description: IPS Ivocolor is a universal stains and glaze assortment consisting of 23 shades of Essence porcelain, 9 shades of Dentin porcelain, 3 incisal porcelains, 2 Glaze powders, 2 glaze pasts, 2 Mixing Liquids, Essence fluid and shade guides. The range of products has been coordinated with the layering, press and CAD Ceramics from Ivoclar Vivadent and the zirconium oxides from Wieland Dental and be used regardless of the CTE of the ceramic. The difference is that IPS Ivocolor can be used with both metal-ceramic and fullceramic materials.

Indications for Use:

Staining and/or characterization and glazing of ceramic materials from Ivoclar Vivadent and Wieland Dental:

Veneering ceramics -
Press ceramics -
-Milling ceramics
Zirconium oxide (frameworks and full-contour restorations) -

Comparison to Predicate: The primary predicate devices to which IPS Ivocolor has been compared are IPS 99 One and IPS 99 Ceram (K121359). Eris Layering Materials (K012174) have also been used as a reference. Ivocolor's indication for individualized staining, characterization and glaze of ceramic materials is the same as IPS 99 shades, stains and glaze. For this application, IPS Ivocolor has been compared to its primary predicate with regard to the chemical compositions, physical properties, operating principals and indications for use. The comparison shows that IPS Ivocolor is substantially equivalent to the primary predicate device.

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510(K) SUMMARY

Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized blue font, with the words "passion vision innovation" written in a smaller font below. Above the company name, there is a series of green and blue dots and squares arranged in an arc shape. The logo is clean and modern, reflecting the company's focus on innovation in the dental industry.

Indications for Use	Predicate deviceIPS 99 Ceram (K121359)	IPS Ivocolor
Indications	The IPS 99 system contains shades,stains and glaze materials used for thecharacterization of metal ceramicrestorations.In addition:IPS 99 Ceram is a conventional multi-layer veneering ceramic for thefabrication of metal-ceramic restorationsusing the most popular dental alloys inthe CTE range of 13.8-15.0 x10-6/K (25-500°C).IPS 99 One is a one-layer veneeringceramic for the fabrication of metal-ceramic restorations using the mostpopular dental alloys in the CTE range of13.8-15.0 x10-6/K (25-500°C).IPS 99 is intended to be used for inlays,onlays, veneers and anterior/posteriorPFM crowns.As a reference device, the Eris systemincludes shades, stains and glazematerials (currently sold under the brandname IPS Empress Universal) which areused for the characterization of all-ceramic restorations.In addition, Eris layering materials areporcelain powders used in the pressableceramic system Empress 2, which isused for metal free single unit, andmultiple unit bonded crown and bridgerestorations.	Staining and/or characterization and glazingof ceramic materials from Ivoclar Vivadentand Wieland Dental:- Veneering ceramics- Press ceramics- Milling ceramics- Zirconium oxide (framework and full-contour)
SummaryIndications	IPS Ivocolor is a universal stains and glaze assortment. Its indication forindividualized staining, characterization and glaze of ceramic materials is the same asIPS 99 shades, stains and glaze. IPS Ivocolor Essence are shade materials.The difference is that IPS Ivocolor can be used with both metal-ceramic and full-ceramic materials whereas the primary predicate - IPS 99 shades, stains and glaze -was supplied as part of the IPS 99 system for metal-ceramic and the reference device- Eris Layering Materials - shade, stains and glaze were supplied as part of the Erissystem for full-ceramics
Working principle	IPS 99 shades and stains are used in verysmall amounts and thin layers tocustomize the esthetics of a restoration.The glaze is used for the glaze firing toachieve a shiny surface.Compatible with IPS 99, IPS InLine, IPSInLine PoM.	The Essence and Stains are used in verysmall amounts and thin layers tocustomize the aesthetic of a restoration.The Glaze is used for the glaze firing toachieve a shiny surface.Compatible with:IPS e.max PressIPS e.max CAD (crystalised)IPS e.max Ceram
	The reference device - Eris LayeringMaterials - shades and stains are used invery small amounts and thin layers tocustomize the aesthetics of a restoration.The glaze is used for the glaze firing toachieve a shiny surface.Compatible with IPS Empress CAD, IPSEmpress Esthetic	IPS e.max ZirPressIPS e.max ZirCAD (sintered)IPS Empress CADIPS Empress EstheticIPS StyleIPS InLineIPS d.SIGNIPS ClassicZenostar (sintered)
Summary WorkingPrinciple	The working principle of the new product is the same as the primary predicatedevice and the reference device. The significant difference is that IPSIvocolor will be marketed for use with the whole range of ceramic materialsfrom Ivoclar Vivadent AG and the zirconium oxide ceramic material fromWieland Dental+Technik GmbH.This is a benefit to the dental technician because he can use a universalproduct.In the past each brand of ceramic was supplied in a system and had its ownshades, stains and glaze.
	Technically it was not difficult to develop shade, stains and glaze which arecompatible with a range of ceramics because the material is applied in verysmall quantities and very thin layers. The potential tension which can bedeveloped between the shade, stains and glaze and the ceramic materials isminimal and does not cause a compatibility problem. It was only necessary toensure that the CTE of the shade, stains and glaze is not above that of theceramic material and this has been achieved.
SummaryComposition	The key ingredients, the silica-based dental glass ceramic are the same asthe primary predicate device. IPS Ivocolor includes a new pigment. Thebiocompatibility of the new formulation was fully assessed and is equivalent toIPS 99
Physical Properties	The product has been tested to ISO 6872 and meets the requirements.	The product has been tested to ISO 6872 and meets the requirements.IPS Ivocolor is the same Type and Class material as the primary predicate.The device has been tested for the following physical properties according to ISO 6872:Uniformity Cleanliness Radioactivity of ceramic Color Coding Flexural Strength Coefficient of Linear Thermal Expansion Glass Transition Temperature Chemical Solubility
Summary Physical properties	The CTE and Glass transition temperature for IPS Ivocolor are slightly lower than those of the primary predicate. This is to ensure that the new materials are compatible with the chosen range of ceramics.

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510(K) SUMMARY

Image /page/5/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the words "passion vision innovation" written in smaller font below. Above the company name are a series of green and blue dots. The logo is simple and modern, and it conveys a sense of innovation and quality.

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510(K) SUMM Revise

IPS Ivocolor

Image /page/6/Picture/2 description: The image is the logo for Ivoclar Vivadent. The logo is blue and green. The words "Ivoclar Vivadent" are in blue, with the first word on top of the second. Below the second word are the words "passion vision innovation" in red.

Conclusion:

IPS Ivocolor is a ceramic material to stain, characterize and glaze ceramic restorations. It is compatible with several ceramic materials, both metal-ceramic and full-ceramic which is a benefit for the user. The indications, performance and biocompatibility match those of existing products, including the primary predicate IPS 99 and the reference device Eris Layering Materials.

Therefore IPS Ivocolor is substantially equivalent to the primary predicate device, IPS 99 One and IPS 99 Ceram (K121359).

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.