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510(k) Data Aggregation
K Number
K200580Device Name
FotoDent denture
Manufacturer
Dreve Dentamid GmbH
Date Cleared
2020-11-19
(259 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Dreve Dentamid GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FotoDent® denture is a light curing resin intended for manufacturing of full and partial removable dentures.
Device Description
FotoDent® denture is a light curable resin for 3D printing of full and partial dentures.
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K Number
K190571Device Name
StoneBite and StoneBite scan
Manufacturer
Dreve Dentamid GmbH
Date Cleared
2019-11-07
(246 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
Dreve Dentamid GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.
StoneBite® is indicated for:
- bite registrations
- I key for intraoral registration
StoneBite® scan is indicated for:
- i bite registrations
- key for intraoral registration
- . optical collection of data in CAD/CAM/CIM systems
Device Description
StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.
StoneBite and StoneBite scan are vinyl polysiloxane based materials.
StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.
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K Number
K171562Device Name
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
Manufacturer
Dreve Dentamid GmbH
Date Cleared
2018-04-13
(318 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
Dreve Dentamid GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dynax® Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
Device Description
Dynax® Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal and dental implant. Base and catalyst components are mixed in equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
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K Number
K162408Device Name
Nano Varnish, Plaquit, Lightpaint on Surface
Manufacturer
DREVE DENTAMID GMBH
Date Cleared
2018-04-05
(584 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
DREVE DENTAMID GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Varnish for final coating for resin temporaries to produce a smooth and shiny surface.
Device Description
The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.
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K Number
K171729Device Name
Fixtemp C&B
Manufacturer
Dreve Dentamid GmbH
Date Cleared
2017-12-13
(184 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Dreve Dentamid GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.
Device Description
Fixtemp® C&B is a two-component automatically mixable composite on the basis of multifunctional (meth)acrylates provided in standard double cartridges. The material is dispensed and mixed by cartridge/mixing tip combination and it is used for the manufacturing of temporary crowns and bridges for use until the permanent restoration is fabricated. It can be also used for inlays, onlays and veneers and is available in tooth-colors A1, A2, A3, A3.5, B1, Bleach X and D2. This is a prescription only material. The labeling and working instructions are designed for health care professionals.
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