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510(k) Data Aggregation
K Number
K100510Device Name
CERAMIR CROWN & BRIDGE
Manufacturer
Date Cleared
2010-03-25
(31 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DOXA AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ceramir Crown & Bridge is intended for the permanent cementation of
- Porcelain Fused to Metal Crowns and Bridges .
- Metal (gold etc.) crowns and bridges .
- . Gold inlays and onlays
- . Cast or prefabricated metal posts
- . Strengthened core all-zirconia or all-alumina ceramic crowns and bridges
Device Description
Ceramir Crown & Bridge is a hybrid glass ionomer-ceramic dental cement. The liquid and powder are packed are in a capsule format. The capsule is activated and the powder and liquid is mixed in a mixer before use.
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