LUXEN Zr, LUXEN Smile

K171585 · Dentalmax Co., Ltd. · EIH · Oct 31, 2018 · Dental

Device Facts

• Record ID: K171585
• Device Name: LUXEN Zr, LUXEN Smile
• Applicant: Dentalmax Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Oct 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3bridges and inlay bridges (anterior and molar).

Device Story

LUXEN Zr and LUXEN Smile are zirconia-based dental restorative materials provided as blocks or disks for use with CAD/CAM systems. LUXEN Zr (3Y-TZP) and LUXEN Smile (5Y-TZP) are milled by dental technicians to create custom dental prosthetics, including crowns, bridges, inlays, and onlays. The devices are non-sterile and intended for permanent oral contact. The final restorations are placed by dental professionals to restore tooth function and aesthetics. The materials are selected based on shade and thickness requirements to match patient dentition.

Clinical Evidence

Bench testing only. Performance testing included uniformity, freedom from extraneous materials, radioactivity, chemical solubility, flexural strength, and linear thermal expansion per ISO 6872:2015. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity (ISO 10993-5), oral mucosal irritation (ISO 10993-10), sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11).

Technological Characteristics

Materials: 3Y-TZP (LUXEN Zr) and 5Y-TZP (LUXEN Smile) zirconia powders. Form factors: blocks, disks, Wieland, and D-95 types. Standards: ISO 6872:2015 (Type II, Class 5/4b), ISO 13356, ISO 10993-1. Non-sterile. CAD/CAM compatible.

Indications for Use

Indicated for dental patients requiring all-ceramic inlays, onlays, veneers, crowns, or multi-unit bridges (up to 3 elements) for tooth restoration.

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

• DD Bio ZX2 (K142987)
• DD cube X2 (K150196)

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.

DENTALMAX Co., Ltd Jindong Kim President 50-7, Pungsesandan 2-ro Pungse-myeon, Dongnam-gu, Cheonan-si Chungcheongnam-do, 31217 Kr

Re: K171585

Trade/Device Name: LUXEN Zr, LUXEN Smile Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 25, 2018 Received: October 2, 2018

Dear Jindong Kim:

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

October 31, 2018

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Digitally signed by Mary Mary S. Date: 2018.10.31 Runner -S3/ 08:38:16 -04'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180718

Device Name ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

Indications for Use (Describe) ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

# LUXEN Zr, LUXEN Smile

Date: October 29, 2018

## I. SUBMITTER

DENTALMAX Co., Ltd 50-7, Pungsesandan 2-ro, Pungse-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31217, Republic of Korea TEL : [phone] FAX : [phone] Contact Name: Kim, Jindong Email: [e-mail]

### II. DEVICE NAME

| Name of Device: | LUXEN Zr, LUXEN Smile |
|----------------------------|-----------------------------------|
| Regulation Name: | Powder, Porcelain |
| Classification Name: | Porcelain powder for clinical use |
| Classification regulation: | 872.6660 |
| Regulatory Class: | 2 |
| Product Code: | EIH |

### III. PREDICATE DEVICE

K142987, DD Bio ZX2, Dental Direkt of Amerika UG K142987, DD cube X2, Dental Direkt of Amerika UG

#### IV. DEVICE DESCRIPTION

LUXEN Zr and LUXEN Smile are used for custom made dental restorations using a CAD/CAM system. The LUXEN Zr and LUXEN Smile are provided in 4 different shapes - block, disk, Wieland and D-95. The LUXEN Zr is composed of 3 mol% TZP. LUXEN Smile is composed of 5 mol% TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia, and ISO 6872:2015 Type2, class 4b for 5Y-TZP Zirconia, respectively.

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There are various color and thickness for LUXEN Zr and LUXEN Smile; LUXEN Zr

- . Shade
- White, S1, S2, S3, E0, E1, E2, E3, E4, Multi-ivory
- . Thickness
- Block type: 10, 12, 14, 15, 16, 18, 20, 22, 25
- Disk type: 10, 12, 14, 16, 18, 20, 22, 25
- Wieland type / D95 type: 10, 12, 14, 16, 18, 20, 22, 25, 30

LUXEN Smile

- . Shade
- White, S1, S2, S3, E0, E1, E2, E3, E4, Multi-white, Multi-ivory
- . Thickness
- Block type: 16
- Disk type: 10, 12, 14, 16, 18, 20, 22, 25
- Wieland type / D95 type: 10, 12, 14, 16, 18, 20, 22, 25, 30

# V. INDICATIONS FOR USE

LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.

LUXEN Smile is indicated for the production of full ceramic crowns, onlays, 3bridges and inlay bridges (anterior and molar).

# VI. COMPARISON TO PREDICATE DEVICE

LUXEN Zr

| Characteristics | Subject Device | Predicate Device | Summary |
|-----------------|---------------------|--------------------------------|---------|
| Device Name | LUXEN Zr | DD Bio ZX2 | - |
| Manufacturer | DENTALMAX CO., LTD. | Dental Direkt of Amerika<br>UG | - |
| 510(k) Number | K171585 | K142987 | - |

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| Classification Name | Porcelain powder for clinical use | Porcelain powder for clinical use | Both products are porcelain powder for clinical use. |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EIH | EIH | Both products are EIH. |
| Device Class | II | II | Both products are class II. |
| Indications for Use | LUXEN Zr is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks. | DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges. | Both products are indicated for dental restorations. |
| Blank configuration | Block type<br>Disk type<br>Wieland type<br>D-95 type | Block type<br>Disk type<br>Wieland type<br>D-95 type | Both products are block, disk, wieland and D-95 types. |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Both products are 10-25mm of thickness. |
| Crystal Morphology | 3Y-TZP | 3Y-TZP | Both products are 3Y-TZP. |
| Color | A0, A1, A2, A3, B1, B2, B3, B4, C4, B1-B2-B3-B4 LAYER | A0, A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 | Similar<br>Both product are met with VITA shade guide. Shade is an option that is selected according to patient's teeth color. Application of appropriate color that matches patient's teeth tone can be possible. |
| Sintering temperature | LUXEN Zr ST : 1580 °C<br>Others : 1500 °C | 1450 °C | Similar<br>The sintering temperature is not exactly same, but each product has provided the optimum temperature.<br>LUXEN Zr is higher than predicate device, but it is confirmed that the temperature improves translucent for nature color shade. |
| Types,<br>Class(ISO6872:2015) | Type II Class 5 | Type II Class 5 | Both products are type II Class 5. |
| Chemical<br>composition(wt.%) | Zirconia Powder Zpex<br>ZrO2+HfO2+Y2O3<br>>99.8 | ZrO2+HfO2+ Y2O3 : ≥99<br>Y2O3 : <6 | Similar<br>The raw material of |
| | | | |
| | Other oxides : <0.2 | Al2O3 : <<0.15<br>Other oxides : <0.15 | LUXEN Zr (Zpex, Zpex Yellow, Zpex Pink / Manufacturer: Tosoh) is consisted of less amount of aluminium oxide than predicate device due to translucency. However, both products meet the requirement of ISO 13356 (Al2O3 ≤ 0.5%).<br><br>Also, Zpex Yellow or Zpex Pink contain Fe2O3 or Er2O3, respectively, while predicate device contains Fe2O3, Er2O3 and MnO2. However, both products meet the requirement of ISO 13356 (other oxide < 0.5%). |
| | ZrO2 : 83-92 | | |
| | Y2O3 : 4-6 | | |
| | HfO2 : <5 | | |
| | Al2O3 : 0.03-0.07 | | |
| | SiO2 : Max 0.02 | | |
| | Fe2O3 : 0.12-0.18 | | |
| | Zirconia Powder Zpex Yellow<br>ZrO2+HfO2+Y2O3 : >99.8<br>Other oxides : <0.2<br>ZrO2 : 83-92<br>Y2O3 : 4-6<br>HfO2 : <5<br>Al2O3 : 0.03-0.07<br>SiO2 : Max 0.02<br>Fe2O3 : 0.12-0.18 | | |
| | Zirconia Powder Zpex Pink<br>ZrO2+HfO2+Y2O3 : >99.8<br>Other oxides : <0.2<br>ZrO2 : 79-92<br>HfO2 : <5<br>Er2O3 : 8-11<br>Al2O3 : 0.03-0.07<br>SiO2 : Max 0.02<br>Fe2O3 : Max 0.01 | | |
| Flexural strength(MPa) | 1038 ± 135 | 1250 | Similar Flexural strength is slightly lower, but higher than required by ISO 6872 for Class 5 dental ceramics(>800 MPa). |
| Thermal expansion coefficient(20-500°C)<br>Coefficient of thermal expansion | 10.7 X 10-6K-1 | 10 X 10-6K-1 | Both products are 10 X 10-6K-1. |
| Chemical solubility(µg/cm²) | 0 | Not listed | - |
| Biocompatibility | Device is biocompatible when used as directed by dental professionals per ISO 10993-1. | ISO 10993 and ISO 7405 | Both products are biocompatible. |
| Sterile | Non-sterile | Non-sterile | Both products are non-sterile. |
| Characteristics | Subject Device | Predicate Device | Summary |
| Device Name | LUXEN Smile | DD cube X2 | - |
| Manufacturer | DENTALMAX CO., Ltd. | Dental Direkt GmbH | - |
| 510(k) Number | K171585 | K150196 | - |
| Classification Name | Porcelain powder<br>for<br>clinical use | Porcelain powder<br>for<br>clinical use | Both<br>products<br>are<br>porcelain powder<br>for<br>clinical use. |
| Product Code | EIH | EIH | Both products are EIH. |
| Device Class | II | II | Both products are class<br>II. |
| Indications for Use | LUXEN Smile is indicated<br>for the production of<br>of full ceramic crowns,<br>onlays, 3- bridges and<br>inlay bridges(anterior<br>and molar). | Dental blanks made<br>from DD cubeX2 are<br>indicated for crowns,<br>multi-unit bridges (up to<br>a maximum of 3<br>elements) and inlay<br>bridges. Applications<br>include both, anterior<br>and posterior bridges. | Both<br>products<br>are<br>indicated for<br>dental<br>restorations. |
| Blank configuration | Block type<br>Disk type<br>Wieland type<br>D-95 type | Disk type<br>Wieland type | Both products are Disk<br>and Wieland type. |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Both products are 10-<br>25mm of thickness. |
| Crystal Morphology | 5Y-TZP | 5Y-TZP | Both products are 5Y-<br>TZP. |
| Color | A0, A1, A2, A3, B1, B2,<br>B3, B4, C4, A1-A2-B3-B4<br>LAYER,<br>B1-B2-B3-B4<br>LAYER | A0, A1, A2, A3, A3.5,<br>B2, C2, D3 | Similar<br>Both product are met<br>with VITA shade guide.<br>Shade is an option that is<br>selected according to<br>patient's teeth color.<br>Application of<br>appropriate color that<br>matches patient's teeth<br>tone can be possible. |
| Sintering temperature | 1450 °C | 1450 °C | Both products are<br>1450 °C. |
| Types,<br>Class(ISO6872:2015) | Type II Class 4b | Type II Class 4 | The proposed device<br>LUXEN Smile is a Type II<br>class 4b device |
| Chemical composition | Zirconia Powder Zpex Smile<br>ZrO2+HfO2+Y2O3 : >99.8<br>Other oxides : <0.2<br>ZrO2 : 80-92<br>Y2O3 : 8-10<br>HfO2 : <5<br>Al2O3 : 0.04-0.06<br>SiO2 : Max 0.02<br>Fe2O3 : <0.1<br><br>Zirconia Powder Zpex Yellow<br>ZrO2+HfO2+Y2O3 : >99.8<br>Other oxides : <0.2<br>ZrO2 : 83-92<br>Y2O3 : 4-6<br>HfO2 : <5<br>Al2O3 : 0.03-0.07<br>SiO2 : Max 0.02<br>Fe2O3 : 0.12-0.18<br><br>Zirconia Powder Zpex Pink<br>ZrO2+HfO2+Y2O3 : >99.8<br>Other oxides : <0.2<br>ZrO2 : 79-92<br>HfO2 : <5<br>Er2O3 : 8-11<br>Al2O3 : 0.03-0.07<br>SiO2 : Max 0.02<br>Fe2O3 : Max 0.01 | ZrO2+HfO2+ Y2O3 : ≥99<br>Y2O3 : <10<br>HfO2 : ca.0.2<br>Al2O3 : <0.1<br>Other oxides : ≤0.05 | 6872:2015 standard<br>while the predicate device DD cube X² is a<br>Type II class 4 (Catalog, Dental Direkt GmbH) in accordance with ISO 6872:2008 standard.<br>Similar<br>The raw material of LUXEN Smile (Zpex Smile, Zpex Yellow, Zpex Pink / Manufacturer: Tosoh) is consisted of less amount of aluminium oxide than predicate device due to translucency. However, both products meet the requirement of ISO 13356 (Al2O3 ≤ 0.5%).<br>Also, Zpex Yellow or Zpex Pink contain Fe2O3 or Er2O3, respectively, while predicate device contains Fe2O3, Er2O3 and MnO2. However, both products meet the requirement of ISO 13356 (other oxide < 0.5%). |
| Flexural strength | 770 ± 66 MPa | > 750-800 MPa | Similar<br>Flexural strength is slightly lower, but higher than required by ISO 6872 for Class 4b dental ceramics(>500 MPa). |
| Thermal expansion coefficient(20-500°C)<br>Coefficient of thermal expansion | $10.3 X 10^{-6}K^{-1}$ | $10 X 10^{-6}K^{-1}$ | Both products are $10 X 10^{-6}K^{-1}$ . |
| Chemical solubility | 0 μg/cm² | 15 μg/cm² | Similar<br>The lower value of |
| | | | chemical solubility has<br>more stable, and both<br>results of meet the<br>requirement of ISO 6872<br>for Class 4b dental<br>ceramics(>2000 $\mu$ g/cm2).<br>Therefore, it is<br>equivalent. |
| Biocompatibility | Device is biocompatible<br>when used as directed<br>by dental professionals<br>per ISO 10993-1. | EN ISO 10993-1, -5 | Both products are<br>biocompatible. |
| Sterile | Non-sterile | Non-sterile | Both products are non-<br>sterile.…