Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a material (zirconia disc) used in a CAD/CAM process for dental restorations. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the material properties and biocompatibility.

Therapeutic

No.
The device is a material (zirconium oxide disc) used to produce dental restorations like crowns and bridges, which are prosthetic devices, not therapeutic devices.

Diagnostic

No

This device is a material (zirconia disc) used for producing dental restorations (e.g., crowns, bridges) via CAD/CAM processing, which is a manufacturing process, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device is a physical material (zirconia disc) used for creating dental restorations, not a software program. The description focuses on the material composition and physical properties, not software functionality.

IVD (In Vitro Diagnostic)

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 production of dental ceramic restorations (inlays, onlays, veneers, artificial teeth, crowns, and bridges) for placement in the mouth. This is a therapeutic and restorative purpose, not a diagnostic one.
Device Description: The device is a material (zirconia disc) used to create physical dental prosthetics. It is not designed to analyze biological samples or provide diagnostic information.
Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological substance or condition for the purpose of diagnosis, monitoring, or screening.
Intended User/Care Setting: The intended users are dental laboratories and dental technicians, who are involved in the fabrication of dental prosthetics, not typically in performing in vitro diagnostic tests.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device is used to create a physical restoration that is placed in vivo (inside the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing, The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

Product codes

EIH

Device Description

KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM system by dental professionals. The subjected device has disc shapes and various shades and thicknesses as follow. Please refer to Appendix 7 for the list of model names and specifications for KDF Zirconia Disc.
Monochromatic shade: Pure
MT series: MT-BL1, MT-BL2, MT-BL3, MT-A1, MT-A2, MT-A3, MT-A3.5, MT-A4
MU series: MU-Pure, MU-BL1, MU-BL2, MU-BL3, MU-A1, MU-A2, MU-A3, MU-A3.5, MU-A4
Diameter (mm): 98.5
Thickness (mm): 10, 14, 16, 18, 20, 22, 25, 30, 35

KDF Zirconia Disc is mainly composed of zirconium oxide (ZrO2) and contain other oxides as stabilizers or/and colorants. The device is two different classifications according to ISO 6872: 2015 depending on shades. MU series are classified as type II class 4 ceramic, otherwise are classified as type II class 5 ceramic.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anterior teeth and posterior teeth areas (for dental ceramic restorations).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental laboratory or dental technician.

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)

Non-clinical testing data are submitted to demonstrate substantial equivalence following FDA recognized standards:

·ISO 6872:2015, Dentistry Ceramic materials
•ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
•ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

The biocompatibility studies were performed in accordance with ISO 10993 series.

a) Performance Testing:
Performance testing of the KDF Zirconia Disc was performed in accordance with ISO 6872:2015. All test results indicate that the devices conform to the requirements of the standard and falls under Type II Class 5 ceramic or Class 4 ceramic as with the predicates. It was concluded that KDF Zirconia Disc has substantially equivalent physical properties and performance to the predicate devices.

Tests performed and results:

Uniformity and Freedom from extraneous materials: No pigment unbalance and foreign material was identified. Passed.
Activity Concentration: The radioactivity concentration (238U) of all samples was less than 1.0 Bq/g. Passed.
Flexural Strength: The flexural strength of MT series with fully sintering were all greater than 800 MPa; similarly for MU series, all test articles showed greater than 500 MPa. Passed.
Chemical Solubility: The chemical solubilities of all fully sintered test articles were all less than 100 µg/cm2. Passed.
Coefficient of Thermal Expansion: The coefficients of thermal expansion for all fully sintered test articles were all within the range of (10.7±0.5) ×10-6 K-1. Passed.
Shrinkage Factor: The shrinkage factor of MT and MU with fully sintering showed 1.217~~1.226±0.002 and 1.225~~1.235±0.002, respectively. Passed.

b) Biocompatibility:
The biocompatibility risk assessment of KDF Zirconia Disc was performed according to ISO 10993-1:2018 and ISO 7405:2018. The tests conducted in accordance with the ISO 10993 series described above showed no significant adverse effects under the conditions of the studies. Based on the results of these studies, the risk of the biocompatibility-related hazards from the use of the device is extremely low, and all biocompatibility risks of the device are determined acceptable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K171585, K192262

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains 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.

July 14, 2022

DENKEN-HIGHDENTAL Co., Ltd. Noriko Tanji 24-3 Kisshoin Ishiharakyomichi-cho Minami-ku, Kyoto 601-8356 JAPAN

Re: K221429

Trade/Device Name: KDF Zirconia Disc Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 10, 2022 Received: May 16, 2022

Dear Noriko Tanji:

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 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

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices 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)

K221429

Device Name KDF Zirconia Disc

Indications for Use (Describe)

K.DF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing, The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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3

K221429

Traditional 510(k) Premarket Notification: KDF Zirconia Disc

5. 510(k) Summary

Date of Preparation: May 10, 2022

Applicant:

DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, 601-8356, Japan Contact Person: Daijiro Goto Manager of Overseas Sales Dept. Phone: +81 75-672-2124 Fax: +81 75-672-2125 e-mail: gotou-dai(@awi.co.jp

Contact:

Noriko Tanji Quality Assurance Group DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, 601-8356, Japan Phone: +81-75-672-2124 Fax:+81 75-672-2136 e-mail: tanji-nor@awi.co.jp

Manufacturer:

Manufactured by DENKEN-HIGHDENTAL Co., Ltd. Address; 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, Kyoto, 601-8356, Japan

Name of Device(s):

Trade Name:	KDF Zirconia Disc
Common Name	Dental appliance fabrication materials, ceramic
Regulation Name(s):	Powder, Porcelain
Classification Name:	Porcelain powder for clinical use

4

Regulation Number:	872.6660
Regulatory Class:	II
Product Code:	EIH
Panel:	Dental

Predicate Device

Primary Predicate Device:

LUXEN Zr, LUXEN Smile (K171585) by DENTALMAX Co., Ltd.

Secondary Predicate Device:

Dental Zirconia Blocks (K192262) by De Corematrix Co., Ltd.

Device Description

KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM system by dental professionals. The subjected device has disc shapes and various shades and thicknesses as follow.

Please refer to Appendix 7 for the list of model names and specifications for KDF Zirconia Disc.

Shade
Monochromatic shade	Pure
MT series	MT-BL1, MT-BL2, MT-BL3,
MT-A1, MT-A2, MT-A3, MT-A3.5, MT-A4
MU series	MU-Pure, MU-BL1, MU-BL2, MU-BL3
MU-A1、MU-A2、MU-A3、MU-A3.5、MU-A4、
Size
Diameter (mm)	φ 98.5
Thickness (mm)	10, 14, 16, 18, 20, 22, 25, 30, 35

5

KDF Zirconia Disc is mainly composed of zirconium oxide (ZrO2) and contain other oxides as stabilizers or/and colorants. The device is two different classifications according to ISO 6872: 2015 depending on shades. MU series are classified as type II class 4 ceramic, otherwise are classified as type II class 5 ceramic.

Indications for Use

KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

Comparison to Predicate Device
--------------------------------	--	--	--

| | Proposed Device | Primary Predicate Device | | Secondary Predicate Device | Comparison | | | Disk type
Wieland type
D-95 type | Disk type
Wieland type
D-95 type | Disc | | | -MU
$\ge$ 500 MPa | | | | by ISO 6872 for type II
class 5 or class 4
ceramics |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Name | KDF Zirconia Disc | LUXEN Zr | LUXEN Smile | Dental Zirconia Blocks | N/A | Color | -Monochronic
Pure,

-MT series
MT-BL1, MT-
BL2, MT-BL3,
MT-A1, MT-
A2, MT-A3,
MT-A3.5, MT-
A4

6

7

Performance (Non-Clinical) Testing

Non-clinical testing data are submitted to demonstrate substantial equivalence following FDA recognized standards:

·ISO 6872:2015, Dentistry Ceramic materials
•ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
•ISO 10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

The biocompatibility studies were performed in accordance with ISO 10993 series.

a) Performance Testing

Performance testing of the KDF Zirconia Disc was performed in accordance with ISO 6872:2015. As shown in the table below, all test results indicate that the devices conform to the requirements of the standard and falls under Type II Class 5 ceramic or Class4 ceramic as with the predicates.

Therefore, it was concluded that KDF Zirconia Disc has substantially equivalent physical properties and performance to the predicate devices.

8

Test Performed	Acceptance Criteria	Results	Judgment
Uniformity and
Freedom from
extraneous
materials	No pigment unbalance
and foreign materials
shall be found on any of
the top, bottom, or side
surfaces of the disc when
visual inspection is
made.	No pigment unbalance and foreign
material was identified.	Passed.
Activity
Concentration