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510(k) Data Aggregation

    K Number
    K220097
    Device Name
    PRESIDENT The Original
    Manufacturer
    Coltène/Whaledent AG
    Date Cleared
    2022-01-13

    (1 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Coltène/Whaledent AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PRESIDENT The Original Xtra light body / light body / regular body: - Correction material for the corrective impression technique - Injection material for the double mix technique - Injection material for the dual arch technique» - Lining impression material PRESIDENT The Original heavy body: - Impression material for pick-up impression in the double mix technique - Tray material for corrective impression technique - Tray material for dual arch technique PRESIDENT The Original System 360: - Impression material for pick-up impression in the double mix technique - Tray material for corrective impression technique - Tray material for dual arch technique PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft - Impression material for pick-up impression in the double mix technique - Tray material for corrective impression technique
    Device Description
    The subject device family is PRESIDENT The Original which consists of addition type silicone based dental impression materials. PRESIDENT The Original is the relaunch and improved version of the predecessor device PRESIDENT (K811767), which is on the market since 1981. PRESIDENT The Original is a two base system consisting of base and catalyst that are mixed together before use. The product portfolio of the subject device PRESIDENT The Original can be broadly subdivided into tray materials and wash materials, according to their physical and chemical properties. The tray materials have a higher tear strength and elasticity than the wash materials. PRESIDENT The Original System 360 devices are surface activated and thixotropic with fast pressure build up so that the wash material is driven into the clinically critical areas. PRESIDENT The Original putties are offered in three different end hardness` for each individual case. PRESIDENT The Original wash materials are stable but also free-flowing under pressure to capture all details precisely. The hydrophilic properties are effected by surfactants in the material. In contact with moisture these additives move to the surface and decrease the surface tension, resulting in an improved wettability. Furthermore, new colors were added to provide a better contrast between wash and tray materials and to allow a more accurate detail readability. PRESIDENT The Original family devices are addition type sillicone-based dental impression materials composed of polyvinylsiloxanes, addition type/surface silicone elastomers in various compositions to achieve different viscosities and flow properties depending on the intended use. To start the curing process the base material needs to be mixed with the corresponding catalyst material. The setting occurs via an addition reaction. The base materials consist of polyvinylsiloxanes, inorganic silicon fillers and other additives (e.g. coloring pigments). In all PRESIDENT The Original family members, except the putty consistencies, surfactants are used to increase hydrophilicity of the impression material.
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