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510(k) Data Aggregation
K Number
K063714Device Name
AXCEL FLOW
Manufacturer
Date Cleared
2007-01-31
(48 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
TRI DENTAL INNOVATORS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- Restoration of minimally invasive cavity preparations (including occuusal pits and fissures)
- Conservative anterior restorations (Classes III and IV)
- Base/liner under direct restorations
- Repair of fillings and veneers
Device Description
AXCEL FLOW is a visible light cure resin-based flowable restorative dental composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for class III, class IV and class V restorations. It utilizes the same resin components found in AXCEL restorative composite. The cured product has high strength and a high surface luster.
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K Number
K051931Device Name
AXCEL
Manufacturer
Date Cleared
2006-02-17
(219 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
TRI DENTAL INNOVATORS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- For direct restorations, for use in all classes of cavities, including veneers and incisal edge repairs.
- For indirect anterior and posterior restorations, including inlays, onlays, and veneers.
Device Description
AXIOM is a light-cured hybrid dental restorative composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for dental filings. The cured product has a high surface luster, high strength and good wear resistance.
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