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510(k) Data Aggregation
K Number
K142446Device Name
Fixtemp Cement
Manufacturer
EXACTA DENTAL DIRECT, INC
Date Cleared
2015-06-04
(275 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
EXACTA DENTAL DIRECT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FixTemp ™ Cement is a dental luting agent indicated for:
- temporary cementation of provisional crowns and bridges,
- cementing of semi-permanent implants.
Device Description
The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.
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K Number
K102917Device Name
FIXTEMP C&B
Manufacturer
EXACTA DENTAL DIRECT, INC
Date Cleared
2011-06-17
(259 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
EXACTA DENTAL DIRECT, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.
The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.
Device Description
The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges.
FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification.
The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.
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