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510(k) Data Aggregation
K Number
K052780Device Name
DENTAPLAST HOT, MODEL 16-XXX
Manufacturer
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
Date Cleared
2005-12-21
(79 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.
Device Description
Dentaplast hot is a polymerizing denture resin on the basis of methylmetacrylate. Dentaplast hot allows to obtain extended processing time and offers fine flowability and is therefore matched with the Dentaplast hot casting sstem. The catalyst is free from tertiary amine and ensures high colour stability. Dentaplast is entirely cadmium-free.
Application range:
-Fabrication of full dentures in the resin casting technique
-Completion of CoCr dentures
-Relinings and shaping of functional margins
-any type of repair work such as cracks, fractures.
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K Number
K052779Device Name
BRECOMP
Manufacturer
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
Date Cleared
2005-12-20
(78 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Brecomp is intended to restore carious lesions or structural defects in teeth.
Device Description
Bre.comp dentine/enamel/transparent is a light curing microhybride for anterior and posterior restorations. Bre.comp is based on BIS-GMA resins and inorganic fillers with particle size of 0.05 to 0.09 µm. The total filler content is 81% (weight percent) and 63% (volume percent). The composite material complies with the requirements of DIN EN ISO 4049.
Application range:
Universal dental restorative material for the following indications:
- cavity classes I to V
- inlays, veneers (direct and indirect)
- crown suprastructures
- post and core buildups
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K Number
K052781Device Name
BREFORMANCE
Manufacturer
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
Date Cleared
2005-12-09
(67 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
Device Description
breformance ColdCuringPolymer is a C+B material for temporary restorations
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