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Found 26 results
510(k) Data Aggregation
K Number
K111855Device Name
HY-BOND RESIGLASS
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2011-11-17
(141 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.
Device Description
Not Found
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K Number
K110235Device Name
BEAUTIBOND MULTI
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2011-05-13
(107 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.
Device Description
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K Number
K110252Device Name
BEAUTIBOND MULTI PR PLUS
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2011-05-13
(105 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BeautiBond Multi PR Plus is dental adhesive to ceramic, consisting primarily of surface treatment material (silane coupling agent). This product is intended for bonding composite resin to ceramics other than alumina and zirconia or composite resin to repair fractured restorations or prostheses.
Device Description
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K Number
K101603Device Name
BEAUTIFIL FLOW PLUS
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2010-08-23
(76 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.
Device Description
Beautifil Flow Plus is a light-curing dental filling material having low viscosity.
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K Number
K101621Device Name
LITE ART
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2010-08-23
(75 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LITE ART is dental resin-based stain material intended to harmonize the color of polymer-based C&B composite resin restorations with surrounding natural dentition. Specific usage of this product is as follows: 1) To characterize and modify C&B composite resin or acrylic resin restorations and 2) To characterize and modify hard resin teeth and acrylic resin teeth.
Device Description
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K Number
K093559Device Name
VINTAGE MP
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2010-03-03
(105 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VINTAGE MP is paste or powder porcelain intended to fabricate metal-ceramic restorations. It is used in conjunction with precious alloys for metal-ceramic restoration, metals for metal-ceramic restoration and stain materials for metalceramic restoration in order to produce natural looking restorations and prostheses.
Device Description
VINTAGE MP is paste or powder porcelain
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K Number
K082744Device Name
BEAUTIBOND
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2008-12-11
(84 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BeautiBond is a light-cured single-component dental adhesive intended to bond dental filling material to cavity or lesion including dentin or enamel for filling restorations of both anterior and posterior teeth.
Device Description
BeautiBond is a light-cured single-component dental adhesive.
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K Number
K080517Device Name
RESICEM
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2008-06-11
(107 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RESICEM is a dual cured, visible light cured, and self cured dental adhesive resin cement and is intended for adhesion between any two of the following: dental restoration, dental restorative material, dental device, and natural teeth.
Device Description
Not Found
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K Number
K080834Device Name
VINTAGE ART
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2008-06-11
(78 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.
Device Description
Vintage Art is dental ceramic stain.
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K Number
K080068Device Name
BEAUTIFIL OPAQUER
Manufacturer
SHOFU DENTAL CORP.
Date Cleared
2008-02-28
(49 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SHOFU DENTAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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