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510(k) Data Aggregation
K Number
K073475Device Name
SYSTEM PLUS
Manufacturer
Date Cleared
2008-03-10
(90 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL DENTAL LABORATORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
System Plus is a vinyl polysiloxane dental impression material. It is ideal for one-step impressions to reproduce the structure of a patient's teeth and gums to produce crowns, bridges, inlays, partial and complete dentures, denture repairs, implants and other dental restorations prescribed by a dentist.
Device Description
System Plus is an addition-reaction silicone impression material. This vinyl polysiloxane (VPS) impression material comes in two different viscosities intended to help reproduce the structure of a patient's teeth and gums in order to produce, crowns, bridges, implants, and other dental restorations.
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