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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?
Applicant Name (Manufacturer) :
PERMA LABORATORIES
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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