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510(k) Data Aggregation
K Number
K011762Device Name
HI-WAVE; POUR-PLUS
Manufacturer
Date Cleared
2001-08-23
(77 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
DENPLUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.
Device Description
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K Number
K991996Device Name
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
Manufacturer
Date Cleared
1999-09-08
(86 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
DENPLUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMPACT-PLUS, IMPACT-20, DP97, DP97-20 are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.
Device Description
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