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510(k) Data Aggregation
K Number
K023742Device Name
SCULPTURE PLUS NANO-HYBRID COMPOSITE
Manufacturer
PENTRON LABORATORY TECHNOLOGIES
Date Cleared
2003-01-17
(71 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON LABORATORY TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material. It is indicated for use, in cured form, to restore carious lesions or structural defects or lost tooth structure either by itself or in combination of metal/ceramic/polymeric substrates and conditioners such as bonding, luting, etching agents commonly used in tooth restoration. The curing can be processed using photo and/or heat curing devices. The curing can accomplished in air, under vacuum or under pressure without or with inert atmosphere.
Device Description
Sculpture Plus Nano-Hybrid Composite is an indirect or direct/indirect dental restorative material.
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K Number
K023499Device Name
GOLD CORE PLUS
Manufacturer
PENTRON LABORATORY TECHNOLOGIES
Date Cleared
2003-01-13
(87 days)
Product Code
EJH
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
PENTRON LABORATORY TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.
Device Description
Not Found
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K Number
K023501Device Name
GOLD CORE 35
Manufacturer
PENTRON LABORATORY TECHNOLOGIES
Date Cleared
2002-12-18
(61 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
PENTRON LABORATORY TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crown, bridges,. implant superstructures and substrate for low fusing, high expansion porcelains and composites. .
Device Description
Gold Core 35 is a noble, yellow alloy to be used for inlays, onlays, single crowns, bridges, implant superstructures and substrates for low fusing, high expansion porcelains and composites. Gold Core 35 is substantially equivalent to Gold Core 55, K993173 with the exception of a minor few elements. However, the addition of these elements does not affect safety and effectiveness.
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K Number
K023502Device Name
JEWEL CAST PLUS
Manufacturer
PENTRON LABORATORY TECHNOLOGIES
Date Cleared
2002-12-18
(61 days)
Product Code
EJH
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
PENTRON LABORATORY TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites.
Device Description
Jewel Cast Plus is a dental alloy that is designed for use as crowns, bridges and substrate for high expansion low fusing dental porcelains and indirect composites. Jewel Cast Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast III with the exception of an element. However, addition of an element does not affect safety and effectiveness because it dramatically improves the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in dental alloys for over 30 years.
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K Number
K020555Device Name
SONATA MICRO HYBRID COMPOSITE
Manufacturer
PENTRON LABORATORY TECHNOLOGIES
Date Cleared
2002-04-22
(61 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
PENTRON LABORATORY TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
Device Description
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
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