Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and mechanical performance of a ceramic block, with no mention of AI or ML algorithms for design, processing, or analysis.

Therapeutic

No
The device is a ceramic block used to create dental restorations, which are considered prosthetics or restorative devices, not therapeutic devices. Therapeutic devices are typically used for treating or curing a disease or condition.

Diagnostic

No

The device is a ceramic block used to create dental restorations, not to diagnose a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states that LUXEN 5G is a ceramic block, which is a physical material, not software. The performance studies and key metrics also relate to the physical properties of the ceramic block.

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 restorations (inlays, bridges, onlays, veneers). This is a therapeutic or restorative purpose, not a diagnostic one.
Device Description: The device is a ceramic block used to create physical dental prosthetics. It's a material for fabrication, not a tool for analyzing biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
Performance Studies: The performance studies focus on the physical and chemical properties of the material (flexural strength, solubility, thermal expansion, biocompatibility), which are relevant to its use as a dental restorative material, not a diagnostic test.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

LUXEN 5G is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.

Product codes

EIH

Device Description

LUXEN 5G is ceramic block used to create customized dental restorations using CAD/CAM system. LUXEN 5G block are available in three shapes (Block, Wieland, D95) and various thickness sizes. LUXEN 5G is composed of yttria-stabilized zirconia and 3~4 mol % TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia.

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)

Performance Tests including Visual, Dimensions, Packaging, Uniformity, Freedom from extraneous materials, Chemical Solubility, Flexural Strength, Linear Thermal Expansion, Flexural Strength in accordance with ISO 6872.
Biocompatibility tests in accordance with ISO 10993-5, 10, 11, and 23.
Pyrogen Test in accordance with USP .

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

Flexural Strength (Mpa): >800Mpa
Thermal expansion coefficient (20-500°C): 11.0 X 10-6 K-1
Chemical solubility (µg/cm²):

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

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

September 30, 2024

Dentalmax Co., Ltd % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. Contact Address

Re: K241151

Trade/Device Name: LUXEN 5G Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: INOTE: Use date of most recent supplementl Received: April 25, 2024

Dear Priscilla Chung:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).

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Sincerely,

Bobak Shirmohamm adi -S

For Michael E. Adjodha, M. Ch.E., RAC, CQIA 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

Submission Number (if known)

K241151

Device Name

LUXEN 5G

Indications for Use (Describe)

LUXEN 5G is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.

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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K241151 - 510(k) Summary

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 2/1/2024

1. Submitter

DENTALMAX Co., Ltd. 50-7, Pungsesandan 2-Ro, Pungse-Myeon, Dongnam-Gu Cheonan-Si, Chungnam, South Korea, 31217

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160, Irvine CA 92612 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

Trade Name: LUXEN 5G
Common Name: Dental Frame Material for Dental Prosthesis
Classification Name: Porcelain Powder for Clinical Use ●
Product Code: EIH
. Classification regulation: 21 CFR 872.6660

4. Predicate Device:

LUXEN ZR by DENTALMAX Co., Ltd. (K171585)

5. Description:

LUXEN 5G is ceramic block used to create customized dental restorations using CAD/CAM system. LUXEN 5G block are available in three shapes (Block, Wieland, D95) and various thickness sizes. LUXEN 5G is composed of yttria-stabilized zirconia and 3~4 mol % TZP. The weight of yttria is classified in accordance with ISO 6872:2015 Type2, class 5 for 3Y-TZP Zirconia.

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6. Indication for use:

LUXEN 5G is indicated for the production of all-ceramic inlays, multi-units bridges, onlays, and veneers without zirconium dioxide frameworks.

7. Basis for Substantial Equivalence

1. Comparison Chart

Characteristics	Subject Device	Predicate Device	Summary
Device Name	LUXEN 5G	LUXEN ZR	None
Manufacturer	DENTALMAX CO.,
LTD	DENTALMAX CO.,
LTD	None
510(k) Number	-	K171585	None
Classification Name	Porcelain powder for
clinical use	Porcelain powder for
clinical use	Same
Product Code	EIH	EIH	Same
Device Class	II	II	Same
Indications for Use	LUXEN 5G is indicated
for the production of
allceramic inlays, multi
units bridges, onlays,
and veneers without
zirconium dioxide
frameworks.	LUXEN Zr is indicated
for the production of
allceramic inlays, multi
units bridges, onlays, and
veneers without
zirconium dioxide
frameworks.	Same
Principles of Operation	Zirconia oxide blank is
a material for crowns
and bridges fabricated
by CAD/CAM milling.	Zirconia oxide blank is
a material for crowns
and bridges fabricated
by CAD/CAM milling.	Same
Chemical Composition	Zirconia Powder Zpex
ZrO2+HfO2+Y2O3

various color powders | Zirconia Powder Zpex
ZrO2+HfO2+Y2O3
various color powders | Similar | |
| Physical Characteristics & Mechanical Properties | | | | |
| Standard Conformed | ISO 6872:2015 | ISO 6872:2015 | Same | |
| Classification | Type II Class 5 | Type II Class 5 | Same | |
| Flexural Strength (Mpa) | >800Mpa | 1038 ± 135 Mpa | Similar | |
| Thermal expansion
coefficient(20-500°C) | 11.0 X 10-6 K-1 | 10.7 X 10-6 K-1 | Similar | |
| Coefficient of thermal
expansion | | | | |
| Chemical solubility(µg/cm²) | 30d) | Externally
communicating device in
oral mucosa, enamel, and
dentin; and contact
duration of C-long term
(>30d) | Same | |

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2. Substantial Equivalence Discussion

The subject device has the same indications for use, principle of operation, and similar chemical compositions.

The main components (ZrO2 + Hfo2 + Y2O3) and their content are similar to the comparator device, but the content of some elements is slightly different. However, the added elements are in very small amounts (800Mpa).

Based on the information submitted herein, we determined that the subject device is substantially equivalent to the predicate device.

8. Non-Clinical Testing

Performance Tests including Visual, Dimensions, Packaging, Uniformity, Freedom ● from extraneous materials, Chemical Solubility, Flexural Strength, Linear Thermal Expansion, Flexural Strength in accordance with ISO 6872
Biocompatibility tests in accordance with ISO 10993-5, 10, 11, and 23 ●
Pyrogen Test in accordance with USP ●

9. Conclusion

The subject device and the predicate device have the same intended use and have the same technological characteristics. Based on the similarities and the test results, we conclude that the subject device is substantially equivalent to the predicate device.