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Found 13 results
510(k) Data Aggregation
K Number
K091512Device Name
BUILD-IT LIGHT CURE
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2009-10-30
(162 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.
Device Description
Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.
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K Number
K081887Device Name
LUTE-IT II VENEER CEMENT, MODEL NO6
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2008-08-29
(58 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K072830Device Name
RM BOND, MODEL J032
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-12-04
(62 days)
Product Code
DYH, EBF
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.
Device Description
The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
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K Number
K072480Device Name
GENERATION 8 SE ADHESIVE
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-11-21
(78 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.
Device Description
The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared. Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.
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K Number
K072545Device Name
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-10-26
(46 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:
- Self-etch base liner
- Restorations of carious lesions
- Class 1, III, and V cavity preparations
- Pit and fissure sealant.
Device Description
The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.
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K Number
K071500Device Name
NANO-BOND II ADHESIVE SYSTEM
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2007-08-10
(71 days)
Product Code
KLE, CLA, EMA
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.
Device Description
Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.
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K Number
K060889Device Name
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2006-10-27
(210 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SE Epiphany Root Canal Sealant is intended for permanent obturation of root canals of teeth in combination with root canal points.
Device Description
The subject device is a self-etch methacrylate resin root canal sealant in a catalyst/base paste formulation. Due to its self-etching and adhering properties, SE Epiphany Root Canal Sealant does not require the use of an etchant, primer or adhesive to achieve its intended function. SE Epiphany Root Canal Sealant has been designed for dual cure capabilities. Device composition is approximately 60-70% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for SE Epiphany Root Canal Sealant is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
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K Number
K060698Device Name
CEMENT-IT ALL PURPOSE, MODEL N97
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2006-05-10
(55 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cement-It All Purpose product is intended for cementation of porcelain, resin and metal-based inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
Device Description
The subject device is a self-etch adhesive resin cement in a catalyst/base paste formulation and is a dual cure luting agent. Due to its self-etching and adhering properties, Cement-It All Purpose does not require the use of an etchant, primer or adhesive. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Cement-It All Purpose is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.
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K Number
K052106Device Name
SIMILE FLOW
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2005-10-31
(89 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K052349Device Name
AVANTE LED CURING UNIT, MODEL N44
Manufacturer
PENTRON CLINICAL TECHNOLOGIES
Date Cleared
2005-10-21
(53 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CLINICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avante LED curing light is used as a light activation system for dental restorative resins.
Device Description
The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133). Both devices are both used as a light activation system for dental restorative resins.
The physical features of the Avante LED curing light provide the dentist with a compact shape and cordless design to facilitate ease of use while using standard light emitting diode technology for optimum curing functions. The Avante LED curing light provides minimum output of 1.000 MW/cm2 which results in typical curing times of 10 seconds for most composite materials. Peak output is measured at 470nm. Curing time can be set between 1- 40 seconds for greater versatility in individual applications.
Accessories include the Avante light guides which are available in four diameters to accommodate dentist preference and use.
The effective portability of the Avante LED curing light is maintained through use of a charging light which is incorporated into the device stand. Included as well in the charging light is a radiometer display to verify proper light output. Lithium-ion batteries power the device and provide 45 minutes on average between charging times.
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