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K Number
K182118Device Name
armor LC
Manufacturer
Mavrik Dental Systems Ltd
Date Cleared
2019-05-03
(270 days)
Product Code
EIE
Regulation Number
872.6300Why did this record match?
Applicant Name (Manufacturer) :
Mavrik Dental Systems Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.
Device Description
armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.
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