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510(k) Data Aggregation
K Number
K082594Device Name
REMESENSE
Manufacturer
REMEDENT NV
Date Cleared
2009-03-19
(192 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
REMEDENT NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Remesense is intended for the local management of dental sensitivity by patient application of foam strips impregnated with desensitizing gel.
Remesense is indicated for use as a tooth desensitizer.
Device Description
Remesense consists of a tray and impregnated foam strips. The Remesense foam strips are thin flexible foam strips, impregnated with a desensitizing liquid. These strips are designed to relieve dental (hyper) sensitivity by patient application to the affected tooth (teeth). The impregnated foam strips are held in place with trays.
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K Number
K023652Device Name
REMECURE MODEL CL 15E
Manufacturer
REMEDENT NV
Date Cleared
2003-01-09
(71 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
REMEDENT NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Remecure CL-15E produces visible light for the polymerization of dental materials and for tooth whitening.
Device Description
Not Found
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