K18 antimicrobial for use in adhesives, sealants, cements, endodontic sealer
K18 MMA for antimicrobial orthodontic acrylics, dentures, oral devices, partials
K18 HEMA antimicrobial for use in adhesives, sealants, resin systems
K18 IBOA antimicrobial isobornyl acrylate for use in 3D printing resin systems
K21 antimicrobial for cavity cleanser, sealants, mouth rinses
G30 antimicrobial dental glass or silica for composites and resin systems with RI 1.530 and 0.7 micron
G41 antimicrobial dental glass or silica for composites and resin systems with RI 1.541 and 0.7 micron
G50 antimicrobial dental glass or silica for composites and resin systems on AEROSIL OX 50 (Silica)
G55 antimicrobial dental glass or silica for composites and resin systems with RI 1.555 and 0.7 micron
RD70 antimicrobial silica with 7.5% K21 for silicone fluids for silicon mouth guards, resin systems, 15 micron
S171 advanced antimicrobial nanoparticle silsesquioxane with K18.5 methacrylate for use in all resin systems 400-600nm
S1711 advanced antimicrobial nanoparticle silsesquioxane with K18 methacrylate and epoxy for use in all resin systems 400-600nm
Guidance for potential manufacturers
FDA regulatory compliance for cytotoxicity studies.
1) Cytotoxicity study using the ISO Elution Method
2) ISO Guinea Pig Maximization Sensitization Test
3) Oral Mucosal Irritation Study in Hamsters Collar Method 14 Day
FITEBAC PLATFORM CHEMISTRY
This video explains FiteBac’s antimicrobial technology and how it functions on a molecular level.
FITEBAC IN VITRO STUDY RESULTS
This GIF shows biofilm grown inside a root canal as part of an in vitro study.
The bacteria are stained red and as our antimicrobial K18 is introduced, the bacteria die off.
FITEBAC’S LEAD ANTIMICROBIAL MOLECULES
Medical Device Master File Certificate
K-18 QAMS and K-21 QAS
FiteBac can provide access to published research that proves the effectiveness of our antimicrobial agents. They are already present in two FDA-cleared devices which others can cite as predicate devices to speed up FDA-clearance navigation.
FiteBac’s patented antimicrobial molecules are present in multiple dental devices that are cleared by the FDA and they are available for use in various areas of dentistry, such as:
Silicone Mouth Guards
Resin-Modified Glass Ionomers