Isolite Systems has received Health Canada's medical device establishment license (MDEL) to market its Isolite, Isodry dental isolation systems and patented single-use Isolite Mouthpieces.
Available in five sizes, soft Isolite Mouthpieces provide safety during the dental procedure and protect the patient from foreign body aspiration and shielding the tongue and cheek from injury by the handpiece or other dental instruments.
By keeping the patient’s mouth open, the dental isolation systems improve patient management and provide dental professionals unprecedented control of the oral environment.
In addition, the systems improve visibility, controlling suction and oral humidity, and virtually eliminate sources of contamination.
Isolite Systems CEO Sandi Hirsch said, "We want to thank the dentists and dental professionals of Canada for recognizing the benefits of our dental isolation systems for their Canadian patients, and for supporting us during the regulatory process."