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510(k) Data Aggregation
K Number
K220077Device Name
IMICRYL Composite, Composite Flow Materials
Manufacturer
Date Cleared
2022-08-09
(211 days)
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe)
- · Direct anterior & posterior restorations
- · Core Build Ups
- · Splinting
IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza)
- · Class III, V & smaller Class IV restorations
- · Base/liner in Class I & Class II restorations
- · Repair resin, porcelain & acrylic temporary materials
- · Pit & fissure sealant
- · Undercut blockout
- Restoration of minimally invasive cavity preparations
Device Description
IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light.
IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity.
There are differences in viscosity between composites and flowable composites.
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