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510(k) Data Aggregation
K Number
K101771Device Name
RELINE-IT MODEL RELINE-IT
Manufacturer
MAJESTIC DRUG CO., INC.
Date Cleared
2010-09-20
(88 days)
Product Code
EBP
Regulation Number
872.3560Why did this record match?
Applicant Name (Manufacturer) :
MAJESTIC DRUG CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An over the counter temporary Denture Reliner, intended to replace a worn denture lining.
Device Description
The subject device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand. The material contains no Methyl Methacrylate Monomer, no Phthalate Plasticizer, no Bisphenol A, no leachable alcohol and no Cadmium colors.
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K Number
K964773Device Name
DENTEMP ONE STEP
Manufacturer
MAJESTIC DRUG CO., INC.
Date Cleared
1997-02-21
(86 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MAJESTIC DRUG CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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