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510(k) Data Aggregation
K Number
K042196Device Name
SAVEDENT BLUE
Manufacturer
DENFOTEX LIGHT SYSTEMS LTD
Date Cleared
2004-11-01
(80 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENFOTEX LIGHT SYSTEMS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.
Device Description
SAVEDENT The BLUE is a LED based curing light intended to polymerise and therefore cure, harden or set resin or glass ionomer based dental materials used for restorative, sealing or cementing procedures. It is a lightweight handheld unit delivering up to 1000mW/cm2 for set times between 10 and 40 seconds.
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