KDF Zirconia Disc

K221429 · Denken-Highdental Co., Ltd. · EIH · Jul 14, 2022 · Dental

Device Facts

• Record ID: K221429
• Device Name: KDF Zirconia Disc
• Applicant: Denken-Highdental Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jul 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended 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.

Device Story

KDF Zirconia Disc is a dental ceramic material supplied in disc form for CAD/CAM fabrication of restorations (inlays, onlays, veneers, crowns, bridges). Composed of zirconium oxide (ZrO2) with stabilizers and colorants. Used by dental laboratories or technicians to mill custom restorations. The device is non-sterile. Clinical benefit is the provision of durable, biocompatible ceramic dental prosthetics. Healthcare providers use the milled output to restore patient dentition.

Clinical Evidence

Bench testing only. No clinical data. Testing included flexural strength, chemical solubility, thermal expansion, shrinkage factor, and radioactivity concentration per ISO 6872:2015. Biocompatibility evaluated per ISO 10993-1:2018 and ISO 7405:2018.

Technological Characteristics

Material: Zirconium oxide (ZrO2) with stabilizers/colorants. Form: Disc (98.5mm diameter, 10-35mm thickness). Classification: ISO 6872:2015 Type II Class 4 or 5. Sintering temperature: 1500°C. Non-sterile.

Indications for Use

Indicated for production of dental ceramic restorations (inlays, onlays, veneers, artificial teeth, crowns, bridges) via CAD/CAM processing for anterior and posterior teeth. Processed by dental laboratory or technician.

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

• LUXEN Zr, LUXEN Smile (K171585)
• Dental Zirconia Blocks (K192262)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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#### 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)

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 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: [phone] Fax: [phone] 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: [phone] Fax:[phone] e-mail: [e-mail]

#### 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 |

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| 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,<br>MT-A1, MT-A2, MT-A3, MT-A3.5, MT-A4 |
| MU series | MU-Pure, MU-BL1, MU-BL2, MU-BL3<br>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 |

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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<br>Wieland type<br>D-95 type | Disk type<br>Wieland type<br>D-95 type | Disc | | | -MU<br>$\ge$ 500 MPa | | | | by ISO 6872 for type II<br>class 5 or class 4<br>ceramics |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Name | KDF Zirconia Disc | LUXEN Zr | LUXEN Smile | Dental Zirconia Blocks | N/A | Color | -Monochronic<br>Pure,<br><br>-MT series<br>MT-BL1, MT-<br>BL2, MT-BL3,<br>MT-A1, MT-<br>A2, MT-A3,<br>MT-A3.5, MT-<br>A4<br><br>-MU series<br>MU-Pure, MU-<br>BL1, MU-BL2,<br>MU-BL3, MU-<br>A1, MU-A2,<br>MU-A3, MU-<br>A3.5, MU-A4 | A0, A1, A2, A3,<br>A3.5, A4, B1, B2,<br>B3, B4, C1, C2,<br>C3, C4, D2, D3,<br>D4 | A0, A1, A2, A3,<br>B1, B2, B3, B4,<br>C4, A1-A2-B3-<br>B4<br>LAYER, B1-B2-<br>B3-B4 LAYER | White and Colour | All products have a<br>disc type.<br>The shade provided on<br>the type and amounts<br>of pigments contained. | Thermal<br>Expansion<br>Coefficient | 10.7×10-6 K-1 | 10.7×10-6 K-1 | 10.3×10-6 K-1 | Unknown | Same with LUXEN<br>Zr. |
| Manufacturer | DENKEN-HIGHDENTAL Co., Ltd. | DENTALMAX Co., Ltd. | DENTALMAX Co., Ltd. | De Corematrix Co., Ltd. | N/A | Sintering<br>Temperature | 1500°C | LUXEN<br>ST:1580°C<br>Others:1500°C | Zr 1450°C | 1400-1600°C | Similar | Chemical<br>Solubility | <100 µg/cm2 | 0 µg/cm2 | 0 µg/cm2 | <100 µg/cm2 | Chemical solubility of<br>all products conforms<br>to ISO 6872 for type<br>II class 5 or class 4<br>dental ceramics. |
| 510(k) Number | | K171585 | K171585 | K192262 | N/A | Types,<br>Class<br>(ISO 6872:2015) | -Pure and MT<br>Type II Class 5<br><br>-MU<br>Type II Class 4 | Type II Class 5 | Type II Class 4b | Type II Class 5 | Pure and MT are<br>classified in the same<br>type as LUXEN Zr<br>and Dental Zirconia<br>Blocks.<br><br>MU is classified as<br>class 4 ceramics, so<br>meets<br>the<br>requirements of Class<br>4b, under which<br>LUXEN Smile is<br>classified. | Biocompatibility | ISO10993-1 and<br>ISO 7405 | Device is<br>biocompatible<br>when used as<br>directed by dental<br>professionals per<br>ISO 10993-1. | Device is<br>biocompatible<br>when used as<br>directed by dental<br>professionals per<br>ISO 10993-1. | Comply with ISO<br>10993-1:2018,<br>FDA<br>Guidance | All products are<br>biocompatible. |
| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Porcelain powder for clinical use | Porcelain powder for clinical use | Same | Chemical<br>Composition | ZrO2+Y2O3+HfO<br>2: >98<br>Al2O3: <0.5<br>SiO2: <0.05<br>Other inorganic<br>pigments: <1 | Zirconia Powder<br>Zpex<br>ZrO2+HfO2+Y2O3<br>:>99.8<br>Other oxides<br>(Al2O3, SiO2,<br>Fe2O3): <0.2<br><br>Zirconia Powder<br>Zpex Yellow<br>ZrO2+HfO2+Y2O3<br>:>99.8<br>Other oxides<br>(Al2O3, SiO2,<br>Fe2O3): <0.2<br><br>Zirconia Powder<br>Zpex Pink<br>ZrO2+HfO2+<br>Er2O3 :≥99.8<br>Other oxides<br>(Al2O3, SiO2,<br>Fe2O3): <0.2 | Zirconia Powder<br>Zpex Smile<br>ZrO2+HfO2+Y2O3<br>:>99.8<br>Other oxides<br>(Al2O3, SiO2,<br>Fe2O3): <0.2<br><br>Zirconia Powder<br>Zpex Yellow<br>ZrO2+HfO2+Y2O3<br>:>99.8<br>Other oxides<br>(Al2O3, SiO2,<br>Fe2O3): <0.2<br><br>Zirconia Powder<br>Zpex Pink<br>ZrO2+HfO2+<br>Er2O3 :≥99.8<br>Other oxides<br>(Al2O3, SiO2,<br>Fe2O3): <0.2 | White zirconia<br>ZrO2+HfO2+Y2O3<br>: ≥99.0<br>Al2O3: ≤0.5<br>Other oxide: ≤0.5<br><br>Colour Zirconia<br>ZrO2+HfO2+Y2O3<br>≥98.0<br>Fe2O3: <0.3<br>Pr2O3: <0.2<br>Er2O3: <1<br>Other oxide: ≤0.5 | Similar.<br>All products contain<br>ZrO2, Y2O3 and HfO2<br>as the main<br>component and small<br>amount of other oxide.<br>Although there are<br>differences in pigment<br>composition and<br>content, they are very<br>small amounts and do<br>not affect performance<br>and safety. | Sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Product Code | EIH | EIH | EIH | EIH | Same | Flexural Strength | -Pure and MT<br>>800 MPa | 1038±135 MPa | 770 ±66 MPa | >800 MPa | Flexural strength is<br>higher than required | | | | | | |
| Device Class | Class II | Class II | Class II | Class II | Same | | | | | | | | | | | | |
| 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. | LUXEN Zr is indicated for the production of all ceramic inlays, multiunits bridges, onlays, and veneers without zirconium dioxide frameworks. | LUXEN Smile is indicated for the production of of full ceramic crowns, onlays, 3- bridges and inlay bridges (anterior and molar). | Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals. | Similar<br>All products are indicated for dental restorations. | | | | | | | | | | | | |
| Shapes | Disc type | Block type | Block type | Blocks. | Same | | | | | | | | | | | | |

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#### 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.

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| Test Performed | Acceptance Criteria | Results | Judgment |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Uniformity and<br>Freedom from<br>extraneous<br>materials | No pigment unbalance<br>and foreign materials<br>shall be found on any of<br>the top, bottom, or side<br>surfaces of the disc when<br>visual inspection is<br>made. | No pigment unbalance and foreign<br>material was identified. | Passed. |
| Activity<br>Concentration | <1.0 Bq/g of 238U | The radioactivity concentration<br>(238U) of all samples was less than<br>1.0 Bq/g. | Passed. |
| Flexural<br>Strength | MT series: ≥800 MPa<br>MU series: ≥500 MPa | The flexural strength of MT series<br>with fully sintering were all greater<br>than 800 MPa; similarly for MU<br>series, all test articles showed<br>greater than 500 MPa. | Passed. |
| Chemical<br>Solubility | < 100 µg/cm2 | The chemical solubilities of all<br>fully sintered test articles were all<br>less than 100 µg/cm2. | Passed. |
| Coefficient of<br>Thermal<br>Expansion | (10.7±0.5) ×10-6 K-1 | The coefficients of thermal<br>expansion for all fully sintered test<br>articles were all within the range of<br>(10.7±0.5) ×10-6 K-1. | Passed. |
| Shrinkage Factor | MT series:<br>1.217~1.226±0.002<br>MU series:<br>1.225~1.235±0.002 | Passed.<br>The shrinkage factor of MT and<br>MU with fully sintering showed<br>1.217~1.226±0.002 and<br>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.

Therefore, the KDF Zirconia Disc conforms to ISO 10993-1:2018 and ISO

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7405:2018, indicating that the safety of the device is substantially equivalent to the predicates.

#### Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the differences between the proposed device and the predicated device are insignificant in terms of substantial equivalence. The proposed device is substantially equivalent to the predicate device.