(518 days)
Not Found
No
The summary describes dental restoration materials used with a CAD/CAM system, focusing on material composition and physical properties. There is no mention of AI, ML, or any software functionality that would suggest the use of such technologies.
No
The device is a material (zirconia blocks) used for creating dental restorations, not a therapeutic device that directly treats a condition. Its function is to be fabricated into prosthetics.
No
The device is indicated for the production of all-ceramic dental restorations using a CAD/CAM system, not for diagnosing medical conditions.
No
The device description clearly states that the devices are composed of 3 mol% TZP and 5 mol% TZP, which are physical materials used for dental restorations. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that LUXEN Zr and LUXEN Smile are used for the production of custom-made dental restorations (inlays, bridges, crowns, etc.) using a CAD/CAM system. These are materials used to create physical dental prosthetics.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health. Its purpose is purely restorative.
The information provided focuses on the material composition, manufacturing process (CAD/CAM), intended use as dental restorations, and performance testing related to the physical and biocompatible properties of the material. This aligns with the characteristics of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin, Enamel, Oral mucosa (for biocompatibility contact classification)
Natural teeth (implied by orthodontic movement, from the general Indications for Use document, though this is for a different product K180718)
Dental restorations (implied by the intended use)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals (implied by biocompatibility section)
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)
The subject devices, LUXEN Zr and LUXEN Smile, and the predicate devices, DD Bio ZX2 and DD cube X2 were tested for the non-clinical performance including uniformity, freedom from extraneous materials, radioactivity, chemical solubility, flexural strength and linear thermal expansion.
All of test results obtained from these tests indicated that the subject devices, LUXEN Zr and LUXEN Smile, is substantially equivalent to the predicate devices, DD Bio ZX2 and DD cube X2, in terms of physical properties and performance.
The biocompatibility evaluation for the subject devices, LUXEN Zr and LUXEN Smile, was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:
Contact classification:
- External communicating devices: Dentin, Enamel, Oral mucosa
- Categorization by duration of contact: C-Permanent(>30d)
Standard:
- ISO 10993-5:2009, Cytotoxicity(MTT),
- ISO 10993-10:2010, Oral mucous Irritation,
- ISO 10993-10:2010, Sensitization(LLNA), .
- ISO 10993-11:2006, Acute systemic toxicity
The results of test indicated that the subject devices, LUXEN Zr and LUXEN Smile, are considered to be biocompatible and therefore equivalent with its predicate devices, DD Bio ZX2 and DD cube X2 that considered biocompatibility per ISO 10993-1 and ISO 7405.
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.
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.
Not Found
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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3
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 : +82-41-523-3580 FAX : +82-41-523-3581 Contact Name: Kim, Jindong Email: jdkim@hedent.co.kr
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.
4
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 | |
| 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 | ||
| Disk type | |||
| Wieland type | |||
| D-95 type | Block type | ||
| Disk type | |||
| Wieland type | |||
| 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 |
| 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 | ||
| Others : 1500 °C | 1450 °C | Similar | |
| The sintering temperature is not exactly same, but each product has provided the optimum temperature. | |||
| LUXEN Zr is higher than predicate device, but it is confirmed that the temperature improves translucent for nature color shade. | |||
| Types, | |||
| Class(ISO6872:2015) | Type II Class 5 | Type II Class 5 | Both products are type II Class 5. |
| Chemical | |||
| composition(wt.%) | Zirconia Powder Zpex | ||
| ZrO2+HfO2+Y2O3 |
99.8 | ZrO2+HfO2+ Y2O3 : ≥99
Y2O3 : 99.8
Other oxides : 99.8
Other oxides : 800 MPa). |
| Thermal expansion coefficient(20-500°C)
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
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 Smile is indicated
for the production of
of full ceramic crowns,
onlays, 3- bridges and
inlay bridges(anterior
and molar). | Dental blanks made
from DD cubeX2 are
indicated for crowns,
multi-unit bridges (up to
a maximum of 3
elements) and inlay
bridges. Applications
include both, anterior
and posterior bridges. | Both
products
are
indicated for
dental
restorations. |
| Blank configuration | Block type
Disk type
Wieland type
D-95 type | Disk type
Wieland type | Both products are Disk
and Wieland type. |
| Thicknesses | 10 mm to 25 mm | 10 mm to 25 mm | Both products are 10-
25mm of thickness. |
| Crystal Morphology | 5Y-TZP | 5Y-TZP | Both products are 5Y-
TZP. |
| Color | A0, A1, A2, A3, B1, B2,
B3, B4, C4, A1-A2-B3-B4
LAYER,
B1-B2-B3-B4
LAYER | A0, A1, A2, A3, A3.5,
B2, C2, D3 | Similar
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 | 1450 °C | 1450 °C | Both products are
1450 °C. |
| Types,
Class(ISO6872:2015) | Type II Class 4b | Type II Class 4 | The proposed device
LUXEN Smile is a Type II
class 4b device |
| Chemical composition | Zirconia Powder Zpex Smile
ZrO2+HfO2+Y2O3 : >99.8
Other oxides : 99.8
Other oxides : 99.8
Other oxides : 750-800 MPa | Similar
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)
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
The lower value of |
| | | | chemical solubility has
more stable, and both
results of meet the
requirement of ISO 6872
for Class 4b dental
ceramics(>2000 $\mu$ g/cm2).
Therefore, it is
equivalent. |
| Biocompatibility | Device is biocompatible
when used as directed
by dental professionals
per ISO 10993-1. | EN ISO 10993-1, -5 | Both products are
biocompatible. |
| Sterile | Non-sterile | Non-sterile | Both products are non-
sterile. |
6
7
LUXEN SMILE
8
9
VII. PERFORMANCE(NON-CLINICAL) TESTING
The subject devices, LUXEN Zr and LUXEN Smile, and the predicate devices, DD Bio ZX2 and DD cube X2 were tested for the non-clinical performance including uniformity, freedom from extraneous materials, radioactivity, chemical solubility, flexural strength and linear thermal expansion.
All of test results obtained from these tests indicated that the subject devices, LUXEN Zr and LUXEN Smile, is substantially equivalent to the predicate devices, DD Bio ZX2 and DD cube X2, in terms of physical properties and performance.
The biocompatibility evaluation for the subject devices, LUXEN Zr and LUXEN Smile, was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:
Contact classification:
- · External communicating devices: Dentin, Enamel, Oral mucosa
- · Categorization by duration of contact: C-Permanent(>30d)
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Standard:
- · ISO 10993-5:2009, Cytotoxicity(MTT),
- · ISO 10993-10:2010, Oral mucous Irritation,
- ISO 10993-10:2010, Sensitization(LLNA), .
- · ISO 10993-11:2006, Acute systemic toxicity
The results of test indicated that the subject devices, LUXEN Zr and LUXEN Smile, are considered to be biocompatible and therefore equivalent with its predicate devices, DD Bio ZX2 and DD cube X2 that considered biocompatibility per ISO 10993-1 and ISO 7405.
VIII. CONCLUSIONS
The indications for use and technological characteristics of the subject devices and predicate devices are substantially equivalent.