(447 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of coloring liquids and zirconia blocks for dental restorations. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the fabrication of all-ceramic restorations like crowns and bridges, which are used to treat and replace damaged or missing teeth, thus providing a therapeutic benefit to the patient.
No
Explanation: The device described consists of coloring liquids and zirconia blocks used for the fabrication of dental restorations (crowns and bridges). Its intended use is to create physical dental prosthetics, not to analyze or interpret any patient data or perform a diagnostic function.
No
The device description clearly outlines physical components including liquids, brushes, and zirconia blocks, indicating it is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the products are for the "shading of white zirconia ceramic materials" and the "fabrication of all-ceramic single tooth crown and bridgework restorations." This describes a process for creating dental prosthetics, not for testing biological samples or providing diagnostic information.
- Device Description: The description details coloring liquids and zirconia blocks used in a manufacturing process for dental restorations. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a material and associated coloring agents used in the fabrication of dental restorations, which falls under the category of dental devices, not IVDs.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior as well as in the posterior tooth region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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'
3
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 |
| 5135 Golf Road Suite 102 | |
| Skokie, Illinois 60077 | |
| Telephone: 847-679-1610 | |
| Fax: 847-674-5761 | |
| Official Contact: | Debra Williams |
| Representative/Consultant: | Betsy A. Brown |
| B.A. Brown and Associates Inc | |
| Telephone: 847-560-4406 |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Tanaka ZirColorTM Coloring Liquid
Tanaka ZirColorTM Dipping Liquid and
Tanaka Enamel ZRTM Blocks |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Common Name: | Porcelain Powder for Clinical Use
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
4
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.
5
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
Characteristics | Subject Device
Tanaka ZirColor™ Coloring
Liquid, Tanaka ZirColor™
Dipping Liquid and Tanaka
Enamel ZR™ Block | Primary Predicate
Zenotec Color Zr, Zenostar Color
Zr and Zenotec Zr Bridge and Zenostar
Zr Translucent the predicate product cleared
under K#112710 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for 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. | "ZENO Zr Disc" is a group of medical
devices, which is intended to fabricate all-
ceramic dental restorations like crowns and
bridges. It consists of ceramic blanks and
coloring liquids.
"ZENOTEC Zr Bridge" and "ZENOSTAR
Zr translucent" are yttria stabilized
zirconium dioxide (Y-TZP) ceramic
(zirconia) blanks for the CAD/CAM-
production of dental restorations.
"ZENOTEC Color Zr" and "ZENOSTAR
Color Zr" are coloring liquids for the
shading of white zirconia ceramic materials.
The products are intended to be used by
professional dental technicians for
fabrication of all-ceramic single tooth and
bridgework restorations, with one or two
pontics, in the anterior as well as in the
posterior tooth region. |
Table 1: Substantial Equivalence Summary
6
| Technological
Characteristics | Subject Device
Tanaka ZirColor™ Coloring Liquid
and
Tanaka ZirColor™ Dipping Liquid | Primary Predicate
Zenotec Color Zr and Zenostar Color
Zr, the predicate product cleared under
K#112710 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material
Composition | - metallic oxide solution | - acidic metal salt solution |
| Performance
characteristics | Coloring liquids are provided in
various shades which correspond to most tooth
colors. For staining, the zirconia materials have
to be brushed with the liquids (Tanaka
ZirColor™ Coloring Liquid) or to be immersed
into the liquids for 10 -30 seconds (Tanaka
ZirColor™ Dipping Liquid) before sintering at
high temperatures (1450°C – 1500°C for 2
hours). The product has a two year shelf-life and is
provided as non-sterile. The product meets ISO
10993: 2009 Part 5 biocompatibility
requirements. | "ZENOTEC Color Zr" and ZENOSTAR Color
Zr" coloring liquids are provided in various
shades which correspond to every tooth color. For
staining, the zirconia materials have to be
immerged into the liquids (Zenotec Color Zr) or to
be 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 Liquid
and Tanaka ZirColor™ Dipping
Liquid utilizes CAD/CAM technology
to produce the dental zirconia
restoration and ionic metallic oxides to
provide coloring/shading
to the zirconia restoration. The
coloring formulation is applied to the
pre-sintered zirconia restoration using
a brush or by dipping. The restoration
is then sintered in a dental furnace at a
high temperature which causes the
base carrier solution to "burn-off"
leaving behind trace amounts of ionic
metallic oxides that provide the
coloring to the zirconia restoration. | Zenotec Color Zr coloring liquid utilizes
CAD/CAM technology to produce the
dental zirconia restoration and ionic
metallic oxides to provide
coloring/shading to the zirconia restoration.
The coloring formulation is applied to the
pre-sintered zirconia restoration using a
brush or by dipping. The restoration is then
sintered in a dental furnace at a high
temperature which causes the base carrier
solution to "burn-off" leaving behind trace
amounts of ionic metallic oxides that
provide the coloring to the zirconia
restoration. |
| Differences | The only difference between the
ZirColor™ and the Zenotec products
is thier base solutions. ZirColor™ is a
hydrocarbon base solution. | The only difference between the Zenotec
and the Tanaka ZirColor products is their
base solutions.
Zenotec is a
acid/water/alcohol base solution. |
Table 2: Substantial Equivalence Summary
7
Premarket Notification Section 5: Page – 8
| Technological Characteristics | Subject Device
Tanaka Enamel ZRT™ Block | Primary Predicate
Zenotec Zr Bridge and Zenostar
Zr Translucent predicate product
cleared under K112710 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material Composition | - ceramic material,
yttria-stabilized tetragonal zirconia
polycrystals (Y-TZP) | - ceramic material,
yttria (yttrium oxide) stabilized
zirconium dioxide (Y-TZP) |
| Performance
Characteristics | Tanaka Enamel ZRT™ Blocks are
disc shaped and partially sintered dental
ceramic materials composed of yttria-
stabilized tetragonal zirconia polycrystals
(Y-TZP) that meets ISO 6892: 2008, ISO
10993:2009-5, ISO 10993: 2006-10 and ISO
13356: 2008 Standard requirements. The
blocks are available in various shades and
thicknesses. The blocks are sintered at
1450°C-1500°C for 2 hours with a heating
rate of 3°C - 10°C/min and a cooling rate of
5°- 10°C/min. | Zenotec Zr Bridge and Zenostar Zr
Translucent are discoidal shaped and
partially sintered dental ceramic
materials that are composed of yttria
(yttrium oxide) stabilized zirconium
dioxide (Y-TZP) that meets ISO
6872:2008 Standard requirements. Both
models are available in various colors,
translucencies and thicknesses. |
| Principle of Operation | Tanaka Enamel ZRT™ Blocks
utilizes CAD/CAM technology to
produce the dental zirconia
restoration and ionic metallic oxides
to provide coloring/shading to the
zirconia restoration. The coloring
formulation is applied to the pre-
sintered zirconia restoration using a
brush or by dipping. The restoration
is then sintered in a dental furnace at
a high temperature which causes the
base carrier solution to "burn-off"
leaving behind trace amounts of
ionic metallic oxides that provide the
coloring to the zirconia restoration. | Zeno Zr Disc utilizes CAD/CAM
technology to produce the dental
zirconia restoration and ionic
metallic oxides to coloring/shading
to the zirconia restoration. The
coloring formulation is applied to
the pre-sintered zirconia restoration
using a brush or by dipping. The
restoration is then sintered in a
dental furnace at a high temperature
which causes the base carrier
solution to "burn-off" leaving
behind trace amounts of
ionic metallic oxides that provide the
coloring to the zirconia restoration. |
| | | |
Table 3. Substantial Equivalence Summary
8
Premarket Notification Section 5: Page - 8
| Technological Characteristics | Tanaka Enamel ZRTM Blocks | Zenotec Zr Bridge and Zenostar
Zr Translucent predicate product
cleared under K112710 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | There are no differences between the
Tanaka Enamel ZRTM Block and the
Zeno Zr Disc. However, their
coloring solutions used to shade the
zirconia blocks differ in their base
solutions. The ZirColorTM is a
hydrocarbon base solution. | There are no differences between the
Zeno Zr Disc and the Tanaka
Enamel ZRTM Block. However, their
coloring solutions used to shade the
zirconia blocks differ in their base
solutions. The Zenotec Coloring
liquid is a acid/water/alcohol base
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.