Frequently asked questions

How does HRCC work?


The action of the HYBENX family of products is based upon the simple fast-acting
principle of Desiccation Shock Technology® or DST®. DST is a simple physical process
that desiccates (removes water) from the combination of infectious microbial material
and dead cell debris (biofilm) and macromolecules that can coat mucosal epithelium. This
effect denatures (destroys) the molecular structure of this infectious material and loosens
attachment to the mucosal surface. This process occurs within less than a minute after
contact.




What is the clinical/regulatory status of the product?


HRCC is a combination product that has been cleared by the US FDA as safe and
effective for use as a medical device in root canal procedures.




Does DST harm the mouth?


No. Normal mucosal epithelium resists the instant drying process of DST. Incidental
contact with the mucosal epithelium will cause the surface to appear blanched (whitened)
This effect dissipates within a few days as natural rehydration occurs. In addition, the
patient may detect an acidic sour taste or brief stinging under some circumstances. This
is normal and transitory. HYBENX Products have been used in over 8 million oral
applications throughout the world. Less than 0.002% of those applications have resulted
in complaints to EPIEN Medical. Those complaints primarily referenced the undesirable
taste, smell, or brief stinging that can be associated with the product and rarely, an
allergic reaction to sulfa as cautioned in the Instructions for Use.




What are the clinical indications for HRCC?


HRCC is cleared by the FDA for use in root canal procedures as an adjunctive rinse of
tooth root canal systems and adjacent tooth surfaces during standard professional
dental procedures to enhance the removal of post-instrumentation dentinal debris
and smear-layer within the root canal systems. Individuals are further directed to
www.hybenxrootcanalcleanser.com where they can obtain a copy of the US labeling for
HRCC.




What if HYBENX Products contact the skin outside the mouth?


HRCC acts in an extremely slow manner on intact skin and will generally have no effect
upon accidental contact but should be rinsed and removed immediately. Contact for
excessive periods of time could yield a slight warming sensation and can discolor or
damage clothing.





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