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510(k) Data Aggregation
K Number
K011839Device Name
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
Manufacturer
Date Cleared
2002-01-17
(219 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DOXA CERTEX AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DoxaDent is a dental ceramic composed of calcium aluminate cement and oxides that is intended to restore carious lesions or structural defects in teeth. Specifically, DoxaDent is indicated for use as a restorative dental material for permanent application in the treatment of class I, II, and V cavities.
Device Description
DoxaDent™ is a dental ceramic composed of a calcium aluminate cement and oxides, i.e., silica and zirconium oxide, and iron oxide colorants, as a filler material, in a blend of fine irregularly shaped particles ranging from 0.5 to 5 um in diameter and microfine particles having a diameter of 0.02 to 0.2 um. Trace concentrations of iron oxide additives (< 0.05% w/w) and alkali salt accelerators (LiCl, < 0.1% w/w) are included to provide for coloring and to control the rate of hydration, respectively.
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