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Found 24 results
510(k) Data Aggregation
K Number
K073539Device Name
PROVISA CEM
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2008-01-31
(45 days)
Product Code
EMB, EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PROVISA CEM is intended for the cementation of temporary crowns and bridges. PROVISA CEM is free of eugenol. After its removal, it will also not inhibit the polymerisation of a composite cement or composite filling material.
Device Description
PROVISA CEM is a dental cement and is particularly intended for the cementation of temporary crowns and bridges. Such a temporary prosthesis is a necessity for the patient in the period between the preparation of the tooth (or teeth) stump, followed by the impression taking, and the placement and cementation of the final prosthesis. During this period of one week or more, the prepared tooth stump has to be protected against any damage. But also the occlusal relationship of the tooth stump versus neighbouring and antagonist teeth has to be kept unchanged in order to prevent articulation problems upon placing the final prosthesis. A temporary cement should offer sufficient retentive force to keep the temporary prosthesis in situ during the intervening week(s), but at the same time it should enable the dentist to take the prosthesis off without damaging the tooth stump and with no discomfort for the patient. PROVISA CEM is presented in the form of two pastes: a white paste, containing zincand magnesium oxide as the reactive components and a yellow paste, containing fatty acid dimer as the reactive component. Upon mixing homogeneously, controlled by a uniform light yellow colour, a smooth paste with the correct consistency is formed, that can be pressed into a thin, but sufficiently strong cement layer. Through a reaction between the metallic oxides and the fatty acid dimer, a chelatenetwork is formed, that makes the paste harden. The resulting cement is stable and strong enough but not too strong.
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K Number
K072245Device Name
EMULATE ADVANCED
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2007-11-08
(87 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062400Device Name
IMPRESSIX, COLORCHANGE ALGINATE
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2006-11-16
(92 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImprEssix, Colorchange Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Device Description
ImprEssix, Colorchange Alginate is a dental impression material based on alginate.
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K Number
K061267Device Name
SIMULATE, COLOR CHANGE ALGINATE
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2006-07-10
(66 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Simulate, Color Change Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Simulate, Color Change Alginate has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
Device Description
Simulate, Color Change Alginate is a dental impression material based on alginate. It has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
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K Number
K052455Device Name
IMPRESSIX
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2005-11-23
(77 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics
Device Description
ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour.
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K Number
K051207Device Name
CAVEX ORTHOTRACE
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2005-06-21
(41 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is about taking impressions of the oral cavity with the purpose of constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting, high elasticity, high tear resistance, can be poured twice with gypsum and is proven Orthotrace is particularly suited for orthodontics
Device Description
Cavex Orthotrace Alginate impression material
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K Number
K042806Device Name
QUADRANT UNIT-1-BOND
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2004-11-24
(43 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
Device Description
Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
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K Number
K032116Device Name
TULIP COLORSWITCH
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2003-09-30
(83 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tulip Colorswitch is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Device Description
Tulip Colorswitch is a dental impression material based on alginate. Tulip Colorswitch has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.
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K Number
K023466Device Name
TULIP ALGINATE IMPRESSION MATERIAL
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2002-12-13
(58 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tulip Alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Device Description
Tulip Alginate impression material is a dental impression material based on alginate.
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K Number
K020242Device Name
EMULATE FAST SET AND EMULATE REGULAR SET
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
2002-04-17
(84 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
CAVEX HOLLAND B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
emulate Fast Set and emulate Regular Set are dental impression materials based on alginate. They are suitable for taking impressions of the oral cavity with the purpose of constructing a gypsum model that equals the situation in the mouth. They are used for making study models, first impressions for general purpose impressions, situation models, orthodontic impressions etc.
Device Description
emulate Fast Set & emulate Regular Set Alginate Impression Materials
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