Device Dossier

Dental cheek retractor, professional, single-use

Device Dossier for Dental cheek retractor, professional, single-use (Dental cheek retractor, professional, single-use, Class IIa, sponsor Emergo). ARTG…

Intended purpose

The device is a non-sterile, single use device which provides the dental clinician with dental isolation of the teeth being worked on while assisting in controlling the oral environment, which reduces potential contamination. When coupled to a vacuum device, the soft, flexible, non-impinging mouthpiece is inserted into the oral cavity to isolate maxillary and mandibular quadrants simultaneously, retract and protect tongue and cheek, deliver bright, shadowless illumination throughout the oral cavity, continuously aspirate fluids and oral debris, and protect the throat to prevent inadvertent aspiration of dental material or debris. The mouthpiece has an integrated bite block which allows the patient to rest his or her teeth, while allowing the oral cavity to remain open while the clinician performs the dental procedure.

TGA Public Summary