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510(k) Data Aggregation
K Number
K121318Device Name
PROSOFT
Manufacturer
PERMA LABORATORIES
Date Cleared
2012-06-06
(35 days)
Product Code
EBP
Regulation Number
872.3560Why did this record match?
Product Code :
EBP
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
ProSoft™ is an over the counter temporary Denture Reliner kit. The device contains a Polyethyl Methacrylate powder, a liquid Ethyl Alcohol, and a mixing stick. The material contains no Methyl Methacrylate Monomer, no Phtalate Plasticizer, no Bisphenol A, and no Cadmium colors.
The powder and the liquid are to be mixed together with the mixing stick to make the relining material. The relining material is then poured into the denture base and placed into the mouth to make the impression.
Once the impression has cured any excess material is trimmed with a sharp knife.
Can be easily removed with warm water or soaking in a solution of hydrogen peroxide and water overnight.
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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?
Product Code :
EBP
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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