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510(k) Data Aggregation
K Number
K250826Device Name
Multi M Series
Manufacturer
DMAX Co., Ltd.
Date Cleared
2025-06-12
(86 days)
Product Code
EIH, DAT
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DMAX Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi M Series is used in the manufacture of dental prosthesis.
Device Description
Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 278 different shades to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.
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K Number
K173769Device Name
DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
Manufacturer
DMAX CO., LTD.
Date Cleared
2018-03-08
(87 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DMAX CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DMAX coloring liquid, Chang's liquid, Confident coloring liquid, and CAMeleon coloring liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
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 45 shades are available in 15ml, 20ml, 30ml, 40ml and 100ml volumes. We offer the product in four different names: DMAX Coloring Liquid, Chang's Liquid, Confident Coloring Liquid, CAMeleon Coloring Liquid. They are just different names for the same products.
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