(115 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a dental coloring liquid, with no mention of AI or ML.
No
The device is described as a liquid used for coloring dental substructures to match the natural color of a patient's teeth. Its purpose is aesthetic and technical in the dental lab, not for treating or diagnosing any medical condition.
No
Explanation: The device is a coloring liquid used for the "coloration of milled porcelain substructures before sintering" and "individual staining of dental zirconia frameworks and restorations prior to the final sintering." Its purpose is to adjust the color of dental restorations, not to diagnose a medical condition.
No
The device is a liquid used for coloring dental substructures, which is a physical substance, not software.
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 "complete or partial coloration of milled porcelain substructures before sintering" in dental restorations. This is a process performed on a dental device (the substructure) and not on a biological sample from a patient.
- Device Description: The device is a "water-based solution" used for "individual staining of dental zirconia frameworks and restorations." Again, this describes a material used in the creation of a dental prosthesis, not a test performed on a patient sample.
- Lack of Biological Sample Analysis: IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, treatment, or prevention of disease. This device does not interact with or analyze any biological samples.
The device is a material used in the manufacturing process of a dental restoration. It falls under the category of dental materials or devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 100 shades are available in 10ml, 30ml, 50ml, 50ml and 100ml volumes. Luxen CL-Diluent and Luxen CL-Pontic Liquid are used to dilute the color of other products. Luxen CL-Pontic and Luxen-CL Diluent is used to dilute Base liquid and special color liquid.
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
General, mostly adults
Intended User / Care Setting
Trained dental technicians
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 following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Shelf Life Test
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Sensitization & Irritation
- ISO 10993-11 Oral mucosa irritation
- Other bench testing Appearance, Volume, Packaging, Color Stability, Extraction
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.
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December 6, 2021
DENTALMAX Co., Ltd. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612
Re: K212548
Trade/Device Name: LUXEN CL Dental Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 20, 2021 Received: October 7, 2021
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 (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
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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, M.ChE. 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)
K212548
Device Name LUXEN CL Dental Liquid
Indications for Use (Describe)
LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
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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K212548 510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
1. Applicant / Submitter:
DENTALMAX Co., Ltd. 50-7, Pungsesandan 2-Ro, Pungse-Myeon, Dongnam-Gu Cheonan-Si, Chungcheongnamdo, Republic of Korea 31217
2. Submission Correspondent:
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:
| Proprietary Name: | LUXEN CL Dental Liquid |
|---|---|
| Common Name: | Liquid Stain for Dental Zirconium Prosthesis |
| Classification Name: | Porcelain Powder for Clinical Use |
| Classification: | Class II, 21 CFR 872.6660 |
| Classification Product Code: | EIH |
4. Predicate Device:
Aadva Zr Coloring Liquid (K092020) by GC AMERICA Inc.
5. Device Description:
The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth.
4
The liquid has 100 shades are available in 10ml, 30ml, 50ml, 50ml and 100ml volumes.
Luxen CL-Diluent and Luxen CL-Pontic Liquid are used to dilute the color of other products. Luxen CL-Pontic and Luxen-CL Diluent is used to dilute Base liquid and special color liquid.
Indications for Use: 6.
LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- = Shelf Life Test
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Sensitization & Irritation
- ISO 10993-11 Oral mucosa irritation
- Other bench testing Appearance, Volume, Packaging, Color Stability, Extraction
8. Substantial Equivalence
The subject device is compared to the predicate device, Aadva Zr Coloring Liquid (K092020), in the table below.
| Subject device | Predicate device | |
|---|---|---|
| Device Name | LUXEN CL Dental Liquid | Aadva Zr Coloring Liquid |
| 510(k) | - | K092020 |
| Product Code | EIH | EIH |
| Manufacturer | DENTALMAX Co., Ltd. | GC AMERICA Inc. |
| Technology | Water-based with inorganic pigments | Water-based with inorganic pigments |
| Indication for Use | LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering. | Aadva Zr Coloring Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering. |
| Principles of Operation | Brush or immerse zirconia ceramic with coloring liquid before sintering | Brush or immerse zirconia ceramic with coloring liquid before sintering |
| Prescription Use | Prescription only | Prescription only |
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| Target population | General, mostly adults | General, mostly adults |
|---|---|---|
| Type of Packaging | Liquid container | Liquid container |
| Packaging Volume(ml) | 30ml, 50ml and 100ml | - |
| Shade | Various | Various |
| General Physical Form | Liquid | Liquid |
| Sterility | Non-Sterile | Non-Sterile |
The subject device is the same as the predicate device in the indications for use, principle of operation, and device characteristics. Both devices are water-based with inorganic pigments and employs brushing or immersing method for use.
The major difference would be chemical compositions, but we have performed the biocompatibility and other performance tests and the test results support that the subject device is substantially equivalent to the predict device.
9. Conclusion:
Based on the testing results, DENTALMAX Co., Ltd. concludes that the subject device is substantially equivalent to the predicate device.