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510(k) Data Aggregation
K Number
K050571Device Name
ABSOLUTE AMERICA
Manufacturer
Date Cleared
2005-11-02
(243 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
EURODENT S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Absolute America is a dental operative unit intended as an operative tool for therapeutic use on people by personnel highly skilled in dental practices, such as dentists, dental assistants and dental hygienists.
Device Description
Eurodent dental operative unit is an electrical device with air and water connections. It is composed from:
- A patient treatment chair moved electrically -
- an hydric group with cuspidor and inside all suction , water, air and electrical circuits ・
- a dentist's instrument board -
- an assistant board -
- an electrical footswitch that controls same unit functions -
- a dental light
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