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510(k) Data Aggregation
K Number
K983461Device Name
UNI-FLEX RESIN
Manufacturer
Date Cleared
1999-04-13
(194 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
TRANS-ATLANTIC DENTAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
Device Description
Uni-flex Resin is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
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