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510(k) Data Aggregation
K Number
K140247Device Name
MTA FILLAPEX
Manufacturer
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
Date Cleared
2014-04-25
(85 days)
Product Code
KIF
Regulation Number
872.3820Why did this record match?
Applicant Name (Manufacturer) :
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
Device Description
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.
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K Number
K132923Device Name
FUSION SINGLE LINK
Manufacturer
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
Date Cleared
2014-01-03
(107 days)
Product Code
KLE, CLA
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.
Device Description
The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.
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