Search Results
Found 1 results
510(k) Data Aggregation
K Number
K212548Device Name
LUXEN CL Dental Liquid
Manufacturer
DENTALMAX Co., Ltd.
Date Cleared
2021-12-06
(115 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DENTALMAX Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUXEN CL Dental Liquid is a liquid used for the complete or partial coloration of milled porcelain substructures before sintering.
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.
Ask a Question
Page 1 of 1