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510(k) Data Aggregation
K Number
K123761Device Name
VITA ENAMIC STAINS
Manufacturer
INNOVATION MEDITECH GMBH
Date Cleared
2013-03-01
(84 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
INNOVATION MEDITECH GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita Enamic® Stains are indicated for shade customization and characterization of the surface of dental restorations made of hybrid ceramic-resin and resin materials.
Device Description
The Vita Enamic 6 Stains are color Intensive resins used for shade characterization of the The Vita Enamic restorations made from Vita Enamic The shades are supplied in sonder form. This powder is mixed with a liquid and applied in a very thin layer to an Enamic restoration to adjust the shade or create characteristics found in natural teeth, such as cracks, restoration to of the painted restoration is then sealed with a dear light-curing allaze to create a smooth and glossy finish that is resistant to abrasion. The Stains are a dual curing create a sinopon one phymenzation that is prepared outside the mouth.
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