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510(k) Data Aggregation
K Number
K050263Device Name
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
Manufacturer
M.O.C.O.M. SRL
Date Cleared
2006-11-21
(655 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
M.O.C.O.M. SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.
Device Description
MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles.
The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions.
MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load.
An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result.
The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one.
The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.
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