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510(k) Data Aggregation
K Number
K021457Device Name
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
Manufacturer
Date Cleared
2002-08-01
(87 days)
Product Code
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Flex Span Temporary Crown & Bridge Material is intended to be used to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
Device Description
Flex Span Temporary Crown & Bridge Material is to be used on dental patients in a dental office environment. Flexspan has the capability of being dual-cured, ic, visible light cure and/or self-cured. The optional light curing ability will give the dentist a choice of not waiting too long for the material to fully cure, if there is a need to fasten the hardening of the material.
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