Search Results
Found 9 results
510(k) Data Aggregation
K Number
K091613Device Name
TAKE 1
Manufacturer
KERR CORP.
Date Cleared
2009-10-07
(126 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Take I is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
Device Description
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and implant impression techniques. Take 1 is a two-part, base/catalyst - paste/paste system. The product is available in three viscosities, Wash, Tray, and Medium.
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K Number
K090292Device Name
PREMISE MODIFIED
Manufacturer
KERR CORP.
Date Cleared
2009-04-03
(57 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premise Modified is a dental composite restorative material intended to be used in all classes of cavities.
Device Description
The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise Modified is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
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K Number
K081695Device Name
DMC COMPOSITE
Manufacturer
KERR CORP.
Date Cleared
2008-08-12
(56 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations.
DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.
Device Description
DMC Composite is a light-cure resin composite offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.
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K Number
K072622Device Name
STANDOUT 2
Manufacturer
KERR CORP.
Date Cleared
2007-12-04
(78 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.
Device Description
StandOut 2 is a dental impression material system that is suitable for all crown and bridge, edentulous, orthodontic and impressions StandOut2 is a two-part, base/catalyst -paste/paste system. The product is available in two viscosities, Wash and Tray.
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K Number
K042888Device Name
DEMETRON IDS CURING LIGHT
Manufacturer
KERR CORP.
Date Cleared
2004-11-10
(22 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Demetron I.D.S. is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
Device Description
The LED based Demetron I.D.S. Curing Light is a device used for the polymerization of dental materials. It consists of an LED curing handpiece and flexible cord designed to be connected to a dental chair unit. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output. The dental chair manufacturer's transformer or power supply will provide power for the handpiece.
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K Number
K031484Device Name
STAND OUT
Manufacturer
KERR CORP.
Date Cleared
2003-07-03
(52 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.
Device Description
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.
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K Number
K014179Device Name
DEMETRON LC
Manufacturer
KERR CORP.
Date Cleared
2002-02-04
(46 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Demetron LC is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
Device Description
The Demetron LC curing light is a device used for the polymerization of dental materials. It consists of a gun and a base stand connected by a cord. The base stand will contain an on/off switch, a gun hanger, and a beeper that generates an audible tone at ten second intervals. The gun trigger will turn the light on until the trigger is actuated again to turn off. The fan will run continuously whenever the unit is on.
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K Number
K010994Device Name
TAKE ONE BITE MODIFIED
Manufacturer
KERR CORP.
Date Cleared
2001-04-23
(20 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001655Device Name
PERMLASTIC 2
Manufacturer
KERR CORP.
Date Cleared
2000-08-10
(71 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
KERR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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