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510(k) Data Aggregation
K Number
K222723Device Name
AMBARINO High-Class
Manufacturer
Creamed GmbH & Co. Produktions- und Handels KG
Date Cleared
2022-09-09
(1 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**Creamed GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.
Device Description
The AMBARINO® High-Class CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion than a pure resin (similar to natural enamel). This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use.
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