Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are liguids for the shading of white zirconia ceramic materials. This product is intended to be used by professional dental technicians for fabrication of all-ceramic single tooth crown and bridgework restorations.

Tanaka Enamel ZR™ Blocks are yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) ceramic (zirconia) blanks intended to be used by professional dental technicians for the fabrication of all-ceramic restorations. It is recommended for manufacturing single-tooth and bridgework restorations, like crowns and bridges with one or two pontics, which can be used in the anterior as well as in the posterior tooth region.

Device Description

Tanaka ZirColor™ Coloring Liquid is supplied as twenty different shades (4 ml each) of metallic oxide based liguid used for the shading of white zirconia ceramic materials. The liquid is identified as the following twenty shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, Occlusal, C1, C2, C3, C4, D2, D3, D4 Incisal Dk, Incisal Lt and Pink. A liquid thinner agent comprised solely of the base component contained in the Tanaka ZirColor™ Coloring Liquid (15 ml), and 2 birch wood handle brushes for the application of the coloring agent also are supplied.

Tanaka ZirColor™ Dipping Liquid (50% diluted formulation of the Tanaka ZirColor™ Coloring Liquid) is supplied as sixteen different shades (30 ml each) of metallic oxide based liquid used for the shading of white zirconia ceramic materials. The Tanaka ZirColor™ Dipping Liquid is identified as the following sixteen shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.

Tanaka Enamel ZR™ Blocks are yttria-stabilized zirconium dioxide (Y -TZP) ceramic (zirconia) blanks supplied in the following five shades: neutral, light, medium, dark and body. These shades are achieved by using the different shades of ZirColor™ Liquid noted above. The zirconia blanks are provided as the following ten sizes:
No. 01 98.25 +/- 0.2 mm 10.0+/- 0.1 mm
No. 02 98.25 +/- 0.2 mm 12.0+/- 0.1 mm
No. 03 98.25 +/- 0.2 mm 14.0+/- 0.1 mm
No. 04 98.25 +/- 0.2 mm 16.0+/- 0.1 mm
No. 05 98.25 +/- 0.2 mm 18.0+/- 0.1 mm
No. 06 98.25 +/- 0.2 mm 20.0+/- 0.1 mm
No. 07 98.25 +/- 0.2 mm 22.0+/- 0.1 mm
No. 08 98.25 +/- 0.2 mm 24.0+/- 0.1 mm
No. 09 98.25 +/- 0.2 mm 26.0+/- 0.1 mm
No. 10 98.25 +/- 0.2 mm 29.0+/- 0.1 mm

AI/ML Overview

The provided documentation (K140491) does not describe an AI medical device or a study proving its performance against acceptance criteria in the context of AI. Instead, it is a 510(k) premarket notification for dental products: "Tanaka ZirColor™ Coloring Liquid, Tanaka ZirColor™ Dipping Liquid and Tanaka Enamel ZR™ Blocks."

This document focuses on establishing substantial equivalence to previously cleared predicate devices (ZENO Zr Disc, Zenotec Color Zr, Zenostar Color Zr, Zenotec Zr Bridge, and Zenostar Zr Translucent cleared under K112710) based on intended use, technology, and performance, primarily through material composition and physicochemical testing, not AI performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device. The document simply does not contain this type of information.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are silhouetted in black. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the image.

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

May 20, 2015

Tanaka Dental c/o Ms. Betsy A. Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076

Re: K140491

Trade/Device Name: Tanaka ZirColor" Coloring Liquid, Tanaka ZirColor™ Dipping Liquid and Tanaka Enamel ZRTM Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 25, 2015 Received: April 30, 2015

Dear Ms. Brown:

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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Page 2 - Ms. Betsy A. Brown

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,

Tina
Kiang -S

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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Premarket Notification Section 4: Page - 3

Indications for Use

510(k) Number (if known) K14 04 91

Device Name: Tanaka ZirColor™ Coloring Liquid, Tanaka ZirColor™ Dipping Liquid and Tanaka Enamel ZR™ Block

Indication for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S 2015.05.18 13:11:17-04'00'

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Premarket Notification Section 5: Page - 4

510(k) Summary

Tanaka ZirColor™ Coloring Liquid, Tanaka ZirColor™ Dipping Liquid and Tanaka Enamel ZR™ Blocks

Fax:

847-677-0177

ADMINISTRATIVE INFORMATION

510K Summary preparation date:	May 15, 2015
Manufacturer Name:	Tanaka Dental5135 Golf Road Suite 102Skokie, Illinois 60077Telephone: 847-679-1610Fax: 847-674-5761
Official Contact:	Debra Williams
Representative/Consultant:	Betsy A. BrownB.A. Brown and Associates IncTelephone: 847-560-4406

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Tanaka ZirColorTM Coloring LiquidTanaka ZirColorTM Dipping Liquid andTanaka Enamel ZRTM Blocks
Common Name:	Porcelain Powder for Clinical Use21 CFR 872.6660
Product Code:	EIH
Classification Panel:	Dental Products Panel, Class II
Reviewing Branch:	Dental Devices Branch

INTENDED USE:

Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are liquids for the shading of white zirconia ceramic materials. This products is intended to be used by dental technicians for fabrication of all-ceramic single tooth crown and bridgework restorations.

Tanaka Enamel ZRTM Blocks are yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) ceramic (zirconia) blanks intended to be used by professional dental technicians for the fabrication of all-ceramic restorations. It is recommended for manufacturing single-tooth and bridgework restorations, like crowns and bridges with one or two pontics, which can be used in the anterior as well as in the posterior tooth region

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Premarket Notification Section 5: Page - 5

DEVICE DESCRIPTION:

ZirColor™ Coloring Liquid (15 ml), and 2 birch wood handle brushes for the application of the coloring agent also are supplied.

No. 01 98.25 +/- 0.2 mm	10.0+/- 0.1 mm
No. 02 98.25 +/- 0.2 mm	12.0+/- 0.1 mm
No. 03 98.25 +/- 0.2 mm	14.0+/- 0.1 mm
No. 04 98.25 +/- 0.2 mm	16.0+/- 0.1 mm
No. 05 98.25 +/- 0.2 mm	18.0+/- 0.1 mm
No. 06 98.25 +/- 0.2 mm	20.0+/- 0.1 mm
No. 07 98.25 +/- 0.2 mm	22.0+/- 0.1 mm
No. 08 98.25 +/- 0.2 mm	24.0+/- 0.1 mm
No. 09 98.25 +/- 0.2 mm	26.0+/- 0.1 mm
No. 10 98.25 +/- 0.2 mm	29.0+/- 0.1 mm

EQUIVALENCE TO MARKETED DEVICE:

Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are substantially equivalent in intended use, technology and performance to Zenotec Color Zr and Zenostar Color Zr, the predicate product cleared under K112710.

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EQUIVALENCE TO MARKETED DEVICE (continued):

Primary Predicate ZENO Zr Disc (K112710)

Tanaka Enamel ZR™ Blocks are substantially equivalent in intended use, material, technology, design and performance to Zenotec Zr Bridge and Zenostar Zr Translucent, the predicate product also cleared under K112710.

TechnologicalCharacteristics	Subject DeviceTanaka ZirColor™ ColoringLiquid, Tanaka ZirColor™Dipping Liquid and TanakaEnamel ZR™ Block	Primary PredicateZenotec Color Zr, Zenostar ColorZr and Zenotec Zr Bridge and ZenostarZr Translucent the predicate product clearedunder K#112710
Indicationfor Use	Tanaka ZirColor™ ColoringLiquid and Tanaka ZirColor™Dipping Liquid are liquids forthe shading of white zirconiaceramic materials. This productis intended to be used byprofessional dental techniciansfor fabrication of all-ceramicsingle tooth crown andbridgework restorations.Tanaka Enamel ZR™ Blocksare yttria-stabilized tetragonalzirconia polycrystals (Y-TZP)ceramic (zirconia) blanksintended to be used byprofessional dental techniciansfor the fabrication of all-ceramicrestorations. It is recommendedfor manufacturing single-toothand bridgework restorations,like crowns and bridges withone or two pontics, which canbe used in the anterior as well asin the posterior tooth region.	"ZENO Zr Disc" is a group of medicaldevices, which is intended to fabricate all-ceramic dental restorations like crowns andbridges. It consists of ceramic blanks andcoloring liquids."ZENOTEC Zr Bridge" and "ZENOSTARZr translucent" are yttria stabilizedzirconium dioxide (Y-TZP) ceramic(zirconia) blanks for the CAD/CAM-production of dental restorations."ZENOTEC Color Zr" and "ZENOSTARColor Zr" are coloring liquids for theshading of white zirconia ceramic materials.The products are intended to be used byprofessional dental technicians forfabrication of all-ceramic single tooth andbridgework restorations, with one or twopontics, in the anterior as well as in theposterior tooth region.

Table 1: Substantial Equivalence Summary

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TechnologicalCharacteristics	Subject DeviceTanaka ZirColor™ Coloring LiquidandTanaka ZirColor™ Dipping Liquid	Primary PredicateZenotec Color Zr and Zenostar ColorZr, the predicate product cleared underK#112710
MaterialComposition	- metallic oxide solution	- acidic metal salt solution
Performancecharacteristics	Coloring liquids are provided invarious shades which correspond to most toothcolors. For staining, the zirconia materials haveto be brushed with the liquids (TanakaZirColor™ Coloring Liquid) or to be immersedinto the liquids for 10 -30 seconds (TanakaZirColor™ Dipping Liquid) before sintering athigh temperatures (1450°C – 1500°C for 2hours). The product has a two year shelf-life and isprovided as non-sterile. The product meets ISO10993: 2009 Part 5 biocompatibilityrequirements.	"ZENOTEC Color Zr" and ZENOSTAR ColorZr" coloring liquids are provided in variousshades which correspond to every tooth color. Forstaining, the zirconia materials have to beimmerged into the liquids (Zenotec Color Zr) or tobe brushed with the liquids (Zenostar Color Zr)before sintering at high temperatures (1450°C-1500°C for 2 hours).
Principle of Operation	Tanaka ZirColor™ Coloring Liquidand Tanaka ZirColor™ DippingLiquid utilizes CAD/CAM technologyto produce the dental zirconiarestoration and ionic metallic oxides toprovide coloring/shadingto the zirconia restoration. Thecoloring formulation is applied to thepre-sintered zirconia restoration usinga brush or by dipping. The restorationis then sintered in a dental furnace at ahigh temperature which causes thebase carrier solution to "burn-off"leaving behind trace amounts of ionicmetallic oxides that provide thecoloring to the zirconia restoration.	Zenotec Color Zr coloring liquid utilizesCAD/CAM technology to produce thedental zirconia restoration and ionicmetallic oxides to providecoloring/shading to the zirconia restoration.The coloring formulation is applied to thepre-sintered zirconia restoration using abrush or by dipping. The restoration is thensintered in a dental furnace at a hightemperature which causes the base carriersolution to "burn-off" leaving behind traceamounts of ionic metallic oxides thatprovide the coloring to the zirconiarestoration.
Differences	The only difference between theZirColor™ and the Zenotec productsis thier base solutions. ZirColor™ is ahydrocarbon base solution.	The only difference between the Zenotecand the Tanaka ZirColor products is theirbase solutions.Zenotec is aacid/water/alcohol base solution.

Table 2: Substantial Equivalence Summary

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Premarket Notification Section 5: Page – 8

Technological Characteristics	Subject DeviceTanaka Enamel ZRT™ Block	Primary PredicateZenotec Zr Bridge and ZenostarZr Translucent predicate productcleared under K112710
Material Composition	- ceramic material,yttria-stabilized tetragonal zirconiapolycrystals (Y-TZP)	- ceramic material,yttria (yttrium oxide) stabilizedzirconium dioxide (Y-TZP)
PerformanceCharacteristics	Tanaka Enamel ZRT™ Blocks aredisc shaped and partially sintered dentalceramic materials composed of yttria-stabilized tetragonal zirconia polycrystals(Y-TZP) that meets ISO 6892: 2008, ISO10993:2009-5, ISO 10993: 2006-10 and ISO13356: 2008 Standard requirements. Theblocks are available in various shades andthicknesses. The blocks are sintered at1450°C-1500°C for 2 hours with a heatingrate of 3°C - 10°C/min and a cooling rate of5°- 10°C/min.	Zenotec Zr Bridge and Zenostar ZrTranslucent are discoidal shaped andpartially sintered dental ceramicmaterials that are composed of yttria(yttrium oxide) stabilized zirconiumdioxide (Y-TZP) that meets ISO6872:2008 Standard requirements. Bothmodels are available in various colors,translucencies and thicknesses.
Principle of Operation	Tanaka Enamel ZRT™ Blocksutilizes CAD/CAM technology toproduce the dental zirconiarestoration and ionic metallic oxidesto provide coloring/shading to thezirconia restoration. The coloringformulation is applied to the pre-sintered zirconia restoration using abrush or by dipping. The restorationis then sintered in a dental furnace ata high temperature which causes thebase carrier solution to "burn-off"leaving behind trace amounts ofionic metallic oxides that provide thecoloring to the zirconia restoration.	Zeno Zr Disc utilizes CAD/CAMtechnology to produce the dentalzirconia restoration and ionicmetallic oxides to coloring/shadingto the zirconia restoration. Thecoloring formulation is applied tothe pre-sintered zirconia restorationusing a brush or by dipping. Therestoration is then sintered in adental furnace at a high temperaturewhich causes the base carriersolution to "burn-off" leavingbehind trace amounts ofionic metallic oxides that provide thecoloring to the zirconia restoration.

Table 3. Substantial Equivalence Summary

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Premarket Notification Section 5: Page - 8

Technological Characteristics	Tanaka Enamel ZRTM Blocks	Zenotec Zr Bridge and ZenostarZr Translucent predicate productcleared under K112710
Differences	There are no differences between theTanaka Enamel ZRTM Block and theZeno Zr Disc. However, theircoloring solutions used to shade thezirconia blocks differ in their basesolutions. The ZirColorTM is ahydrocarbon base solution.	There are no differences between theZeno Zr Disc and the TanakaEnamel ZRTM Block. However, theircoloring solutions used to shade thezirconia blocks differ in their basesolutions. The Zenotec Coloringliquid is a acid/water/alcohol basesolution.

Table 3: Substantial Equivalence Summary (continued)

Summarv of Non-clinical Testing:

The Tanaka Enamel ZRTM Blocks were tested and found to conform to the ISO 10993 Biocompatibility Standard requirements for Cytotoxicity, Acute Systemic Oral Toxicity, Sensitization and Oral Mucosa Irritation.

Physiochemical testing in accordance with ISO 13356: 2008 Implants for Surgery-Ceramic Materials based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP) and ISO 6872: 2008 Standards for Dental Ceramics was performed on the Tanaka Enamel ZRTM Blocks

The Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid were also tested and found to conform to the ISO 10993 Biocompatibility Standard for Cytotoxicity, Acute Systemic Oral Toxicity, Sensitization and Oral Mucosa Irritation.

Real-time shelf-life stability testing was conducted on the Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid.

Although the base solutions for the ZirColor™ Coloring and Dipping Liquids and the Zenotec Color Zr and Zenostar Color Liquids are not identical (i.e. hydrocarbon base solution and acid/water/alcohol base solution respectively) the differences do not affect the intended use, performance characteristics, or principle of operation. Testing was conducted to validate the different characteristics and demonstrate that the base solutions allow the metallic oxide particles to adhere to the surface of the zirconia material and provide the desired shading to the tooth structure.

Conclusion for Substantial Equivalence:

Tanaka ZirColor™ Coloring Liguid and Tanaka Zircolor™ Dipping Liquid are substantially equivalent to the predicate products, Zenotec Color Zr and Zenostar Color Zr, which were cleared under K112710.

Also, Tanaka Enamel ZR™ Block is substantially equivalent to the products Zenotec Zr Bridge and Zenostar Zr Translucent, cleared under K112710.

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.