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510(k) Data Aggregation
K Number
K221695Device Name
3M Filtek Supreme Flowable Restorative
Manufacturer
3M Company ESPE Dental Products
Date Cleared
2022-06-13
(3 days)
Product Code
EBF, EBC
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
3M Company ESPE Dental Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Direct Restoration of all cavity classes (I-V)
- Base/liner under direct restorations
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
- Pit and fissure sealant
Device Description
FiltekTM Supreme Flowable Restorative is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. It is available in a variety of tooth-colored shades. Filtek™ Supreme Flowable Restorative contains Bis GMA, TEGDMA, and Procrylat K resins. The fillers are a combination of an Ytterbium Fluoride filler, a non-agglomerated/non-aggregated surface-modified silica filler, and a surface-modified aggregated zirconia/silica cluster filler. The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume). Filtek Supreme Flowable Restorative is applied to the tooth following the use of a methacrylate-based dental adhesive such as manufactured by 3M, which permanently bonds the restoration to the tooth structure. When irradiated by light, the methacrylate functionalities of the resin and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. The product is available in both syringe and capsule delivery systems.
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