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510(k) Data Aggregation
K Number
K180463Device Name
Apoller Flow Light Cure Flowable Composite
Manufacturer
Date Cleared
2018-11-14
(266 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Greenway YW LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indications for use:
*Class III and V restorations
- * Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
*Base/liner under direct restorations
*Repair of small defects in esthetic indirect restorations
*Pit and fissure sealant
*Undercut blockout
*Repair of resin and acrylic temporary materials
Device Description
Apoller Flow-Light Cure Flowable Composite is a low viscosity light activated flowable nanocomposite device. The device is comprised of a syringe with dispensing tips. It consists of methmethacrylate monomers, inorganic fillers and nanoparticles. Apoller Flow Light Cure Flowable Composite contains BisGMA, UDMA, TEGDMA, photo initiator, stabilizer and inorganic fillers including barium glass powder, strontium glass powder and nanosilica. The filler loading is about 56% by weight. The particle size varies from 0.03 to 1 micron. Apoller Flow Light Cure Flowable Composite series is packed in a plastic syringe with a bend metal injection needle heads for ease of usage, its model is Flowable and comes with Refill Syringe of 3.0g /syringe and 1.5 g /syringe. It is available in a variety of 15 tooth-colored shades.
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