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Found 7 results
510(k) Data Aggregation
K Number
K020050Device Name
ENAMEL BONDING SYSTEM
Manufacturer
Date Cleared
2002-02-14
(38 days)
Product Code
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rite-Dent Bonding System creates a bond between and all resin restorative materials. It consists of an Aola Lionany of the surface area for mechanical bonding. The The Librant clonod the onamer is interlock the etched area. After placement of Oatalyst and Dubo intinued and the monded enamel, a chemical bond will form between the composite and the tooth structure.
Device Description
Enamel Bonding System
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K Number
K011822Device Name
PIT AND FISSURE CHEMICAL CURING SEALANT
Manufacturer
Date Cleared
2001-08-07
(57 days)
Product Code
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This is a chemically activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures.
Device Description
Pit and Fissure Sealant
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K Number
K011453Device Name
TOOTH SHADE RESIN MATERIAL
Manufacturer
Date Cleared
2001-07-23
(73 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K010255Device Name
CAVITY VARNISH
Manufacturer
Date Cleared
2001-04-20
(81 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K010240Device Name
POLYCARBOXYLATE (PCA) CEMENT
Manufacturer
Date Cleared
2001-03-27
(61 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K003427Device Name
ZINC PHOSPHATE CEMENT
Manufacturer
Date Cleared
2001-01-24
(82 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K003426Device Name
ALGINATE IMPRESSION MATERIAL
Manufacturer
Date Cleared
2001-01-23
(81 days)
Product Code
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
RITE-DENT MANUFACTURING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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