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Found 8 results
510(k) Data Aggregation
K Number
K170207Device Name
Obturys
Manufacturer
Itena Clinical
Date Cleared
2017-07-31
(188 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
Itena Clinical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K162960Device Name
TotalC-Ram
Manufacturer
ITENA CLINICAL
Date Cleared
2017-03-14
(141 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays.
Device Description
TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
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K Number
K122551Device Name
PROVITEMP
Manufacturer
ITENA CLINICAL
Date Cleared
2013-06-14
(297 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K122521Device Name
PREVENT SEAL
Manufacturer
ITENA CLINICAL
Date Cleared
2013-06-11
(295 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prevent Seal is used by dental profesionnals primarily in young children :
- . To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities :
- . Covering layer or " initial layer " in the fabrication of esthetically demanding composite restorations ; and
- . For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
Device Description
Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
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K Number
K122549Device Name
DENTO TEMP
Manufacturer
ITENA CLINICAL
Date Cleared
2013-04-26
(248 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is intended for: 1) quick temporary cementation of temporary crowns and bridges; 2) rebasing of crowns; and 3) permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired. DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.
Device Description
DentoTemp is a dental long term acrylic-urethane polymer based temporary cement. It does not contain eugenol or zinc oxyde. It is a unique 2-stage polymerization composition which does not harm temporary crowns and does not interfere with permanent cements.
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K Number
K121804Device Name
PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM
Manufacturer
ITENA CLINICAL
Date Cleared
2013-04-19
(304 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TotalCem
The device is intended for the cementation of posts, crowns, bridges, inlays and onlays.
DentoCem
The device is intended for permanent cementation of:
- crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland . bridges and veneers;
- . implant prosthesis:
- orthodontic attachments:
- amalgam restorations:
- veneering of alloys: and ●
- composite restorations. .
Device Description
TotalCem: TotalCem is a permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
DentoCem: DentoCem is a chemical-curing, multi-purpose, dual-cured (auto/photopolymerizable), radio opaque permanent adhesive resin cement comprised of two easy-to-mix components.
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K Number
K122522Device Name
DENTOETCH QUICKBOND BOND ACTIVATOR
Manufacturer
ITENA CLINICAL
Date Cleared
2013-03-19
(211 days)
Product Code
KLE, EBF
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DentoEtch: It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.
Quickbond: It is intended for: Bonding composite to enamel and/or dentin; Bonding veneers, crowns & bridges, onlays and inlays; Bonding composite core built-up material; Bonding of composite to metal, Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers); Treatment of hypersensitive teeth or exposed root surfaces; and Cavity sealing under amalgam restorations
Bond Activator: It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.
Device Description
DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.
Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator
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K Number
K121769Device Name
DENTOCORE / DENTOCORE BODY
Manufacturer
ITENA CLINICAL
Date Cleared
2013-03-05
(263 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
ITENA CLINICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject devices are intended to serve for the fabrication of core build-ups. They are also intended to serve as a base cement to affix pins and posts. They may be used with any Bis-GMA compatible bonding agent.
Device Description
The subject devices are dual-cure (auto and photo), nanofilled resin composite materials. They are stackable for easy setting, with no condensation, radio opaque and fluoride releasing. The subject devices are presented in an Automix syringe and a Cartridge used with a gun. Dentocore and Dentocore Body have the same intended use; the former possessing a relatively higher viscosity. This quality is a selection for practitioners choosing this type of material. The subject devices present numerous advantages, notably the following: Good compressive strength, Low polymerization shrinkage, Fluorure release, Very high radio opacity properties.
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