LUXEN CL Dental Liquid
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212548 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LUXEN CL Dental Liquid is a dental liquid classified under the Dental category, specifically designed for use in oral hygiene and dental procedures. It functions as a cleaning agent, likely intended for disinfection, irrigation, or lubrication in dental applications, ensuring a sterile environment during treatments.
This product is supplied as a liquid and is classified as Single-Use per regulatory submission. It is authorized under FDA 510K and MDD compliance, with a Traditional clearance pathway. The device is intended for use in clinical dental settings and must be stored according to manufacturer guidelines to maintain efficacy. No MRI safety or reusable specifications are noted in the data.
Frequently asked questions
What is the LUXEN CL Dental Liquid primarily used for in dental procedures?
The LUXEN CL Dental Liquid is designed as a cleaning agent for oral hygiene and dental treatments, serving functions like disinfection, irrigation, or lubrication. Its purpose is to help maintain a sterile environment during clinical dental procedures, ensuring safety and cleanliness in the oral cavity.
Is the LUXEN CL Dental Liquid intended for reuse, or is it meant to be used only once?
The LUXEN CL Dental Liquid is classified as a single-use product according to its regulatory submission. This means each bottle is intended for one-time use only, and reuse is not recommended or supported by the manufacturer.
How should I store the LUXEN CL Dental Liquid to keep it effective?
Storage instructions are not explicitly detailed in the provided data, but the manufacturer advises adhering to their guidelines to maintain the product’s efficacy. Typically, dental liquids like this are stored in a cool, dry place away from direct sunlight and extreme temperatures until use.
What regulatory pathways does the LUXEN CL Dental Liquid follow, and how was it cleared?
The LUXEN CL Dental Liquid was cleared through the FDA 510(k) pathway under the Traditional clearance route, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It also complies with the MDD (Medical Device Directive) in its home market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212548 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentalmax Co., Ltd
- FDA Applicant
- Dentalmax Co., Ltd.
Sources (2)
- FDA 510(k) K212548 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026