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Found 36 results
510(k) Data Aggregation
K Number
K020499Device Name
BOND-3 ADHESIVE
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2002-04-22
(67 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bond-3 Adhesive is used for the adhesion of tooth (dentin and enamel) 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
Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) K936222 contain the same materials. However, Bond-3 Adhesive Contains additional Methacryl-POSS for added improvements. Safety and effectiveness have not been affected.
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K Number
K013543Device Name
BOND-1 C & B
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2002-02-22
(128 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.
Device Description
Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.
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K Number
K013542Device Name
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2002-02-14
(120 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.
Device Description
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Dentin Conditioning and Adhesive System, allows the Bond-1 C&B to cure with or without the use of light.
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K Number
K012231Device Name
AVANTE MICRO CRYSTAL SYSTEM
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-08-23
(38 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A vante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations.
Device Description
Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. The composition of Avante Porcelain is similar to that of Synspar Porcelain, K910303. The composition of Available of Avante was adjusted in Avante Porcelain to result in a lower firing temperature compared to Synspar. However, the actual list of chemical compounds present in Avante is similar to that of Synspar.
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K Number
K011748Device Name
FIRST FILL R.C.S.
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-08-03
(58 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.
Device Description
FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points. The resins used in First Fill RCS are the common dental methacrylate resins.
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K Number
K010957Device Name
QUELL DESENSITIZER
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-06-25
(87 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011330Device Name
JP CAST 50
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-06-22
(51 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011331Device Name
JP CAST 40
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-06-22
(51 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011362Device Name
GOLD CORE 73 LS
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-05-29
(26 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010044Device Name
COSMIC
Manufacturer
JENERIC/PENTRON, INC.
Date Cleared
2001-02-09
(35 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
JENERIC/PENTRON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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