K Number
K190436
Device Name
KATANA Zirconia Block
Date Cleared
2019-05-23

(90 days)

Product Code
Regulation Number
872.6660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).
Device Description
The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations. KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.
More Information

No
The summary describes a material (zirconia block) used for fabricating dental restorations and its physical properties. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.

No.
The device is a material for fabricating dental restorations, not a device directly used to treat a disease or condition.

No

The device is a material (zirconia block) used for fabricating dental restorations like crowns and bridges, not for diagnosing medical conditions.

No

The device description clearly states it is a "pre-sintered zirconia block," which is a physical material, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the fabrication of dental restorations (frameworks, crowns, bridges, inlays, onlays, and veneers). This is a direct application within the body for structural support and aesthetics.
  • Device Description: The device is a pre-sintered zirconia block used in a milling system to create these dental restorations.
  • Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is a material used to create a physical restoration for the mouth.

N/A

Intended Use / Indications for Use

KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

Product codes (comma separated list FDA assigned to the subject device)

EIH

Device Description

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations.

KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Bench testing: Physical and mechanical properties of the subject device were evaluated according to ISO 6872: 2015. The results show the subject device, the predicate device and the reference device comply with ISO 6872: 2015.
Biocompatibility testing: The subject device is categorized into the external communicating device (dentin) and permanent contact device. No further biocompatibility testing was necessary as it has the same ingredients and manufacturing process as the predicate and reference devices.

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.

K170986

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.

K143439

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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 23, 2019

Kuraray Noritake Dental Inc. Yasujiro Ohara Manager, Quality Assurance Department Ote Center Bldg. 7F Chiyoda-ku, 100-0004 JAPAN

Re: K190436

Trade/Device Name: KATANA Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 20, 2019 Received: February 22, 2019

Dear Yasujiro Ohara:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known): K190436

Device Name: KATANA Zirconia Block

Indications for Use:

KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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Date: May 13, 2019

510(k) number: K190436

510(k) Summary

3-1. 510(k) owner (submitter)

    1. Name
    1. Address
    1. Contact person
  1. Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Yasujiro Ohara Manager Quality Assurance Department

Manabu Suzuki Director KURARAY AMERICA, INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

3-2. Name of Device

    1. Trade / Proprietary name
    1. Classification name
    1. Common name

3-3. Predicate device

KATANA Zirconia Block

3-4. Reference device KATANA Zirconia

KATANA Zirconia Block

Porcelain powder for clinical use (21 CFR section 872.6660. Product code: EIH)

Dental ceramics

510(k) Number Classification: Product Code: 21 CFR Section: Applicant:

K170986 Porcelain powder for clinical use EIH 872.6660 Kuraray Noritake Dental Inc.

510(k) Number Classification: Product Code: 21 CFR Section: Applicant:

K143439 Porcelain powder for clinical use EIH 872.6660 Kuraray Noritake Dental Inc.

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3-4. Device Description

In this submission, we add a new size [14Z L (a: 17.8×b: 19.2×c: 40.0 mm)] to KATANA Zirconia Block (K170986) and expand to the same indications as KATANA Zirconia (K143439).

Device description of KATANA Zirconia Block is modified as follows.

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations.

KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.

3-5. Statement of Indications for use

KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

3-6. Substantial Equivalence Discussion

  1. Indications for use

The indications of the subject device, the predicate device and the reference device are as listed on the following table.

| | Subject device
(a modification to the
predicate device) | Predicate device
(K170986) | Reference device
(K143439) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade
name | KATANA Zirconia Block | KATANA Zirconia Block | KATANA Zirconia |
| Size | 12Z: 15.3×19.2×20.2
(mm)
14Z: 17.8×19.2×20.2
(mm)
14Z L: 17.8×19.2×40.0
(mm) | 12Z: 15.3×19.2×20.2
(mm)
14Z: 17.8×19.2×20.2
(mm) | $\phi$ 98.5×14 to $\phi$ 98.5×
22 (mm) |
| Indication
s for use | KATANA Zirconia Block is
used for the fabrication of the
ceramic restorations
(frameworks, FCZ crowns,
FCZ bridges (14Z L), inlays,
onlays and veneers). | KATANA Zirconia Block is
used for the fabrication of the
ceramic restorations (FCZ
crowns, inlays, onlays and
veneers). | "KATANA Zirconia" is used
for the fabrication of the
ceramic restorations
(frameworks, FCZ crowns,
FCZ bridges, inlays, onlays
and veneers). |

Table 3-6-1. Indications for useof the subject device, the predicate device and the reference device
--------------------------------------------------------------------------------------------------------------

The indications for useof the subject device was written up based on the predicate device (KATANA Zirconia Block) and the reference device (KATANA Zirconia).

This new size is larger than predicate device, and smaller than reference device (K143439), whose size is 98.5×14 to 22 (mm).Therefore, the indications for useof the subject device is substantially equivalent to the predicate device and the reference device.

2) Chemical ingredients

All ingredients in the subject device have been used in the predicate device and the reference device. Regarding the above predicate device and the reference device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was concluded that the subject device is substantially equivalent in biocompatibility to the predicate device and the reference device.

  1. Technological characteristics

Table 3-6-2 compares the subject device to the predicate device and the reference device with respect to technological characteristics.

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| | Subject device
(a modification to the
predicate device) | predicate device
(K170986) | Remark |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade
name | KATANA Zirconia Block | KATANA Zirconia Block | Subject device and
predicate device are the
same except for new size.
This new size is larger than
predicate device, and
smaller than reference
device (K143439), whose
size is $\phi$ 98.5 × 14 to 22
(mm), and comply with
ISO 6872: 2015 as shown
in 3-7. From the above,
Subject device is
substantially equivalent to |
| Type | ST&STML | ST&STML | |
| Shapes | Block | Block | |
| Sizes | 12Z: 15.3×19.2×20.2
(mm)
14Z: 17.8×19.2×20.2
(mm)
14Z L: 17.8×19.2×40.0
(mm) | 12Z: 15.3×19.2×20.2
(mm)
14Z: 17.8×19.2×20.2
(mm) | |
| Shades | A1, A2, A3, A4, B1, B2,
B3, C1, C2, C3, D2, D3,
NW, CL | A1, A2, A3, A4, B1, B2,
B3, C1, C2, C3, D2, D3,
NW, CL | in 3-7. From the above,
Subject device is
substantially equivalent to |
| Materials | ZrO2+Y2O3+Pigments | ZrO2+Y2O3+Pigments | predicate device and |
| Sintering
status | 1550°C-1560°C | 1550°C-1560°C | reference device. |
| Sterility
status | Non-sterile | Non-sterile | |
| Milling
technique | Place the block into the
milling machine; then
begin the milling process
following the milling
systems technical
instructions. | Place the block into the
milling machine; then
begin the milling process
following the milling
systems technical
instructions. | |

Table 3-6-2. Comparison of Technological characteristics

  1. Non clinical Perfomance Testing

Physical and mechanical properties of the subject device were evaluated according to ISO 6872: 2015. According to ISO 6872:2015, the subject device is classified into the following:

  • Type II: All other forms of ceramic products.

  • Class 4: a) Monolithic ceramic for three-unit prostheses involving molar restoration.

The results of comparative study performed according to ISO 6872: 2015 were indicated Table 3-6-3. The results show the subject device, the predicate device and the reference device comply with ISO 6872: 2015.

Therefore, the performance of the subject device is substantially equivalent to the predicate device and the reference device.

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| Section | | | | Subject device
(a modification to the
predicate device) | Predicate device
(K170986) | Reference device
(K143439) |
|-------------------|--------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------|------------------------------------|
| | | | Requirement | KATANA Zirconia
Block (14Z L) | KATANA Zirconia
Block (12Z, 14Z) | KATANA Zirconia
Disc (ST, STML) |
| 5.1
Uniformity | | | The inorganic pigment(s) used to
produce the color of a fired dental
ceramic and any organic colorants (for
color coding) shall be uniformly
dispersed throughout the dental
ceramic material and in powdered
ceramic products, no segregation of
the pigment(s) shall take place when
the powder is mixed as in 7.1.3. Check
by visual inspection. | COMPLIES | COMPLIES | COMPLIES |
| 5.2 | Freedom
from
extraneous
materials | 5.2.1 | Dental ceramic materials shall be free
from extraneous materials when
assessed by visual inspection. | COMPLIES | COMPLIES | COMPLIES |
| | | 5.2.2 | Dental ceramic materials shall not
have an activity concentration of more
than 1.0 Bq·g-1 of 238U. Test in
accordance with 7.2.2. | COMPLIES | COMPLIES | COMPLIES |
| 5.4 | Physical
and
chemical
properties | Flexural
strength | Equal to or greater than 500MPa. | COMPLIES | COMPLIES | COMPLIES |
| | | Chemical
solubility | Less than 100µg/cm² | COMPLIES | COMPLIES | COMPLIES |
| | | The
coefficient
of thermal
expansion | The coefficient of thermal expansion
of the ceramics shall not deviate by
more than 0.5 × 10-6 K-1 from the
value stated by the manufacturer.
(The value stated by the
manufacturer : 9.8×10-6K-1) | COMPLIES | COMPLIES | COMPLIES |

Table 3-6-3. The results of comparative study performed according to ISO 6872:2015

"COMPLIES" means that test value was in the acceptable range to pass the testing in compliance with the requirements of ISO 6872: 2015.

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The subject device is categorized into the external communicating device (dentin) and permanent contact device.

We evaluated according to ISO 10993-1: 2009, the subject device have the same ingredients and manufacturing process as the predicate device and the reference device and therefore no further biocompatibility testing was necessary.

3-7. Conclusion

The comparison for indications for use, chemical ingredients, technological characteristics shows that the subject device is substantially equivalent to the predicate device and the reference device.