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510(k) Data Aggregation
K Number
K180935Device Name
Infinity / Infinity Cross Flex Dental Systems
Manufacturer
Date Cleared
2020-02-05
(666 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
Olsen Industria e Comercio S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Infinity / Infinity Cross Flex Dental Systems are intended for use in general dental applications by providing the dental practitioner a user interface to control of the dental chair and attached dental devices. The, system delivers air, water and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
Device Description
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