TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS

K140491 · Tanaka Dental · EIH · May 20, 2015 · Dental

Device Facts

• Record ID: K140491
• Device Name: TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS
• Applicant: Tanaka Dental
• Product Code: EIH · Dental
• Decision Date: May 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are liquids 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 Story

System comprises metallic oxide-based coloring liquids (brush-on or dipping) and yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) ceramic blanks. Used by professional dental technicians in dental labs to fabricate all-ceramic restorations. Process: CAD/CAM technology shapes zirconia blank; coloring liquid applied to pre-sintered restoration; restoration sintered in dental furnace (1450°C–1500°C). Sintering burns off base carrier solution, leaving ionic metallic oxides for shading. Final output is a custom-shaded ceramic crown or bridge. Benefits include patient-specific tooth color matching and structural restoration of teeth.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 (cytotoxicity, acute systemic oral toxicity, sensitization, oral mucosa irritation). Physiochemical testing per ISO 13356:2008 (Y-TZP ceramic materials) and ISO 6872:2008 (dental ceramics). Real-time shelf-life stability testing performed.

Technological Characteristics

Materials: Y-TZP ceramic blanks, metallic oxide coloring solutions (hydrocarbon base). Standards: ISO 10993 (biocompatibility), ISO 13356:2008 (Y-TZP), ISO 6872:2008 (dental ceramics). Form factor: Disc-shaped blanks (various sizes/thicknesses), liquid bottles. Processing: CAD/CAM milling, manual liquid application, high-temp sintering (1450°C–1500°C). Non-sterile.

Indications for Use

Indicated for professional dental technicians to fabricate all-ceramic single tooth crowns and bridgework restorations (including one or two pontics) in anterior and posterior regions using white zirconia ceramic materials.

Regulatory Classification

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.

Predicate Devices

• Zenotec Color Zr (K112710)
• Zenostar Color Zr (K112710)
• Zenotec Zr Bridge (K112710)
• Zenostar Zr Translucent (K112710)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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 Dental<br>5135 Golf Road Suite 102<br>Skokie, Illinois 60077<br>Telephone: [phone]<br>Fax: [phone] |
| Official Contact: | Debra Williams |
| Representative/Consultant: | Betsy A. Brown<br>B.A. Brown and Associates Inc<br>Telephone: [phone] |

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Tanaka ZirColorTM Coloring Liquid<br>Tanaka ZirColorTM Dipping Liquid and<br>Tanaka Enamel ZRTM Blocks |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Porcelain Powder for Clinical Use<br>21 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:

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 |

# 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.

| Technological<br>Characteristics | Subject Device<br>Tanaka ZirColor™ Coloring<br>Liquid, Tanaka ZirColor™<br>Dipping Liquid and Tanaka<br>Enamel ZR™ Block | Primary Predicate<br>Zenotec Color Zr, Zenostar Color<br>Zr and Zenotec Zr Bridge and Zenostar<br>Zr Translucent the predicate product cleared<br>under K#112710 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication<br>for Use | Tanaka ZirColor™ Coloring<br>Liquid and Tanaka ZirColor™<br>Dipping Liquid are liquids for<br>the shading of white zirconia<br>ceramic materials. This product<br>is intended to be used by<br>professional dental technicians<br>for fabrication of all-ceramic<br>single tooth crown and<br>bridgework restorations.<br><br>Tanaka Enamel ZR™ Blocks<br>are yttria-stabilized tetragonal<br>zirconia polycrystals (Y-TZP)<br>ceramic (zirconia) blanks<br>intended to be used by<br>professional dental technicians<br>for the fabrication of all-ceramic<br>restorations. It is recommended<br>for manufacturing single-tooth<br>and bridgework restorations,<br>like crowns and bridges with<br>one or two pontics, which can<br>be used in the anterior as well as<br>in the posterior tooth region. | "ZENO Zr Disc" is a group of medical<br>devices, which is intended to fabricate all-<br>ceramic dental restorations like crowns and<br>bridges. It consists of ceramic blanks and<br>coloring liquids.<br><br>"ZENOTEC Zr Bridge" and "ZENOSTAR<br>Zr translucent" are yttria stabilized<br>zirconium dioxide (Y-TZP) ceramic<br>(zirconia) blanks for the CAD/CAM-<br>production of dental restorations.<br><br>"ZENOTEC Color Zr" and "ZENOSTAR<br>Color Zr" are coloring liquids for the<br>shading of white zirconia ceramic materials.<br><br>The products are intended to be used by<br>professional dental technicians for<br>fabrication of all-ceramic single tooth and<br>bridgework restorations, with one or two<br>pontics, in the anterior as well as in the<br>posterior tooth region. |

# Table 1: Substantial Equivalence Summary

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| Technological<br>Characteristics | Subject Device<br>Tanaka ZirColor™ Coloring Liquid<br>and<br>Tanaka ZirColor™ Dipping Liquid | Primary Predicate<br>Zenotec Color Zr and Zenostar Color<br>Zr, the predicate product cleared under<br>K#112710 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material<br>Composition | - metallic oxide solution | - acidic metal salt solution |
| Performance<br>characteristics | Coloring liquids are provided in<br>various shades which correspond to most tooth<br>colors. For staining, the zirconia materials have<br>to be brushed with the liquids (Tanaka<br>ZirColor™ Coloring Liquid) or to be immersed<br>into the liquids for 10 -30 seconds (Tanaka<br>ZirColor™ Dipping Liquid) before sintering at<br>high temperatures (1450°C – 1500°C for 2<br>hours). The product has a two year shelf-life and is<br>provided as non-sterile. The product meets ISO<br>10993: 2009 Part 5 biocompatibility<br>requirements. | "ZENOTEC Color Zr" and ZENOSTAR Color<br>Zr" coloring liquids are provided in various<br>shades which correspond to every tooth color. For<br>staining, the zirconia materials have to be<br>immerged into the liquids (Zenotec Color Zr) or to<br>be brushed with the liquids (Zenostar Color Zr)<br>before sintering at high temperatures (1450°C-<br>1500°C for 2 hours). |
| Principle of Operation | Tanaka ZirColor™ Coloring Liquid<br>and Tanaka ZirColor™ Dipping<br>Liquid utilizes CAD/CAM technology<br>to produce the dental zirconia<br>restoration and ionic metallic oxides to<br>provide coloring/shading<br>to the zirconia restoration. The<br>coloring formulation is applied to the<br>pre-sintered zirconia restoration using<br>a brush or by dipping. The restoration<br>is then sintered in a dental furnace at a<br>high temperature which causes the<br>base carrier solution to "burn-off"<br>leaving behind trace amounts of ionic<br>metallic oxides that provide the<br>coloring to the zirconia restoration. | Zenotec Color Zr coloring liquid utilizes<br>CAD/CAM technology to produce the<br>dental zirconia restoration and ionic<br>metallic oxides to provide<br>coloring/shading to the zirconia restoration.<br>The coloring formulation is applied to the<br>pre-sintered zirconia restoration using a<br>brush or by dipping. The restoration is then<br>sintered in a dental furnace at a high<br>temperature which causes the base carrier<br>solution to "burn-off" leaving behind trace<br>amounts of ionic metallic oxides that<br>provide the coloring to the zirconia<br>restoration. |
| Differences | The only difference between the<br>ZirColor™ and the Zenotec products<br>is thier base solutions. ZirColor™ is a<br>hydrocarbon base solution. | The only difference between the Zenotec<br>and the Tanaka ZirColor products is their<br>base solutions.<br>Zenotec is a<br>acid/water/alcohol base solution. |

# Table 2: Substantial Equivalence Summary

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Premarket Notification Section 5: Page – 8

| Technological Characteristics | Subject Device<br>Tanaka Enamel ZRT™ Block | Primary Predicate<br>Zenotec Zr Bridge and Zenostar<br>Zr Translucent predicate product<br>cleared under K112710 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material Composition | - ceramic material,<br>yttria-stabilized tetragonal zirconia<br>polycrystals (Y-TZP) | - ceramic material,<br>yttria (yttrium oxide) stabilized<br>zirconium dioxide (Y-TZP) |
| Performance<br>Characteristics | Tanaka Enamel ZRT™ Blocks are<br>disc shaped and partially sintered dental<br>ceramic materials composed of yttria-<br>stabilized tetragonal zirconia polycrystals<br>(Y-TZP) that meets ISO 6892: 2008, ISO<br>10993:2009-5, ISO 10993: 2006-10 and ISO<br>13356: 2008 Standard requirements. The<br>blocks are available in various shades and<br>thicknesses. The blocks are sintered at<br>1450°C-1500°C for 2 hours with a heating<br>rate of 3°C - 10°C/min and a cooling rate of<br>5°- 10°C/min. | Zenotec Zr Bridge and Zenostar Zr<br>Translucent are discoidal shaped and<br>partially sintered dental ceramic<br>materials that are composed of yttria<br>(yttrium oxide) stabilized zirconium<br>dioxide (Y-TZP) that meets ISO<br>6872:2008 Standard requirements. Both<br>models are available in various colors,<br>translucencies and thicknesses. |
| Principle of Operation | Tanaka Enamel ZRT™ Blocks<br>utilizes CAD/CAM technology to<br>produce the dental zirconia<br>restoration and ionic metallic oxides<br>to provide coloring/shading to the<br>zirconia restoration. The coloring<br>formulation is applied to the pre-<br>sintered zirconia restoration using a<br>brush or by dipping. The restoration<br>is then sintered in a dental furnace at<br>a high temperature which causes the<br>base carrier solution to "burn-off"<br>leaving behind trace amounts of<br>ionic metallic oxides that provide the<br>coloring to the zirconia restoration. | Zeno Zr Disc utilizes CAD/CAM<br>technology to produce the dental<br>zirconia restoration and ionic<br>metallic oxides to coloring/shading<br>to the zirconia restoration. The<br>coloring formulation is applied to<br>the pre-sintered zirconia restoration<br>using a brush or by dipping. The<br>restoration is then sintered in a<br>dental furnace at a high temperature<br>which causes the base carrier<br>solution to "burn-off" leaving<br>behind trace amounts of<br>ionic metallic oxides that provide the<br>coloring 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 Zenostar<br>Zr Translucent predicate product<br>cleared under K112710 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | There are no differences between the<br>Tanaka Enamel ZRTM Block and the<br>Zeno Zr Disc. However, their<br>coloring solutions used to shade the<br>zirconia blocks differ in their base<br>solutions. The ZirColorTM is a<br>hydrocarbon base solution. | There are no differences between the<br>Zeno Zr Disc and the Tanaka<br>Enamel ZRTM Block. However, their<br>coloring solutions used to shade the<br>zirconia blocks differ in their base<br>solutions. The Zenotec Coloring<br>liquid is a acid/water/alcohol base<br>solution. |

# 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.