IPS Ivocolor

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. 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. {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 (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 {2}------------------------------------------------ ## 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| 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. This section applies only to requirements of the Paperwork Reduction Act of 1995, #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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, AG<br>Bendererstrasse 2, Schaan, FL-9494, Liechtenstein<br>+423-235-3535 | | Date Prepared: | October 27, 2015 | | Proprietary Name: | IPS Ivocolor | | Classification Name: | Powder, Porcelain CFR Regulation (872.6660)<br>(Classification Code EIH) | | Predicate Device: | IPS 99 One and IPS 99 Ceram (K121359) (primary)<br>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. {4}------------------------------------------------ # 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 device<br>IPS 99 Ceram (K121359) | IPS Ivocolor | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications | The IPS 99 system contains shades,<br>stains and glaze materials used for the<br>characterization of metal ceramic<br>restorations.<br><br>In addition:<br>IPS 99 Ceram is a conventional multi-<br>layer veneering ceramic for the<br>fabrication of metal-ceramic restorations<br>using the most popular dental alloys in<br>the CTE range of 13.8-15.0 x10-6/K (25-<br>500°C).<br><br>IPS 99 One is a one-layer veneering<br>ceramic for the fabrication of metal-<br>ceramic restorations using the most<br>popular dental alloys in the CTE range of<br>13.8-15.0 x10-6/K (25-500°C).<br><br>IPS 99 is intended to be used for inlays,<br>onlays, veneers and anterior/posterior<br>PFM crowns.<br><br>As a reference device, the Eris system<br>includes shades, stains and glaze<br>materials (currently sold under the brand<br>name IPS Empress Universal) which are<br>used for the characterization of all-<br>ceramic restorations.<br><br>In addition, Eris layering materials are<br>porcelain powders used in the pressable<br>ceramic system Empress 2, which is<br>used for metal free single unit, and<br>multiple unit bonded crown and bridge<br>restorations. | Staining and/or characterization and glazing<br>of ceramic materials from Ivoclar Vivadent<br>and Wieland Dental:<br>- Veneering ceramics<br>- Press ceramics<br>- Milling ceramics<br>- Zirconium oxide (framework and full-<br>contour) | | Summary<br>Indications | IPS Ivocolor is a universal stains and glaze assortment. Its indication for<br>individualized staining, characterization and glaze of ceramic materials is the same as<br>IPS 99 shades, stains and glaze. IPS Ivocolor Essence are shade materials.<br><br>The difference is that IPS Ivocolor can be used with both metal-ceramic and full-<br>ceramic materials whereas the primary predicate - IPS 99 shades, stains and glaze -<br>was supplied as part of the IPS 99 system for metal-ceramic and the reference device<br>- Eris Layering Materials - shade, stains and glaze were supplied as part of the Eris<br>system for full-ceramics | | | Working principle | IPS 99 shades and stains are used in very<br>small amounts and thin layers to<br>customize the esthetics of a restoration.<br>The glaze is used for the glaze firing to<br>achieve a shiny surface.<br>Compatible with IPS 99, IPS InLine, IPS<br>InLine PoM. | The Essence and Stains are used in very<br>small amounts and thin layers to<br>customize the aesthetic of a restoration.<br>The Glaze is used for the glaze firing to<br>achieve a shiny surface.<br>Compatible with:<br>IPS e.max Press<br>IPS e.max CAD (crystalised)<br>IPS e.max Ceram | | | The reference device - Eris Layering<br>Materials - shades and stains are used in<br>very small amounts and thin layers to<br>customize the aesthetics of a restoration.<br>The glaze is used for the glaze firing to<br>achieve a shiny surface.<br>Compatible with IPS Empress CAD, IPS<br>Empress Esthetic | IPS e.max ZirPress<br>IPS e.max ZirCAD (sintered)<br>IPS Empress CAD<br>IPS Empress Esthetic<br>IPS Style<br>IPS InLine<br>IPS d.SIGN<br>IPS Classic<br>Zenostar (sintered) | | Summary Working<br>Principle | The working principle of the new product is the same as the primary predicate<br>device and the reference device. The significant difference is that IPS<br>Ivocolor will be marketed for use with the whole range of ceramic materials<br>from Ivoclar Vivadent AG and the zirconium oxide ceramic material from<br>Wieland Dental+Technik GmbH.<br>This is a benefit to the dental technician because he can use a universal<br>product.<br>In the past each brand of ceramic was supplied in a system and had its own<br>shades, stains and glaze. | | | | Technically it was not difficult to develop shade, stains and glaze which are<br>compatible with a range of ceramics because the material is applied in very<br>small quantities and very thin layers. The potential tension which can be<br>developed between the shade, stains and glaze and the ceramic materials is<br>minimal and does not cause a compatibility problem. It was only necessary to<br>ensure that the CTE of the shade, stains and glaze is not above that of the<br>ceramic material and this has been achieved. | | | Summary<br>Composition | The key ingredients, the silica-based dental glass ceramic are the same as<br>the primary predicate device. IPS Ivocolor includes a new pigment. The<br>biocompatibility of the new formulation was fully assessed and is equivalent to<br>IPS 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.<br>IPS Ivocolor is the same Type and Class material as the primary predicate.<br><br>The device has been tested for the following physical properties according to ISO 6872:<br>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. | | {5}------------------------------------------------ # 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. {6}------------------------------------------------ # 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).