MOUTH OPENER

INTENDED USE
Silicone dental mouth opener is intended for temporary retraction and sustained opening of the patient’s oral cavity during general dentistry, endodontic treatment, prosthetic restoration, professional oral hygiene and other intraoral procedures.
It is designed to expose the operative field, limit involuntary movement of cheeks and tongue, and improve operational visibility for dental practitioners.

Target Users: Licensed dentists, dental hygienists, qualified professional dental medical staff only.

Intended Limitation: For single patient use only (disposable).

CONTRAINDICATIONS
Do not apply this device to the following patient groups:
– patients with confirmed hypersensitivity or allergy to silicone
– patients with acute temporomandibular joint (TMJ) disorders
– patients with severe oral mucosal lesions, open wounds or acute inflammation at contact areas
– patients with conditions limiting mouth opening
– patients at high risk of choking or aspiration

WARNINGS AND PRECAUTIONS
Do not apply excessive force during compression and placement. Overforce may lead to wire breakage and traumatic damage to oral soft tissue and dentition.
For prolonged procedures, regularly check mucosal pressure points to prevent pressure necrosis, ischemia or soft tissue irritation.
Never leave the device unattended in the patient’s mouth after treatment. Remove immediately once the dental procedure is completed.
The device is non-sterile. Perform sterilization procedure before use in patient.
Keep out of reach of unauthorized personnel and children to prevent accidental ingestion or choking hazards.

STORAGE
Store in a dry, dark, well-ventilated area
Keep away from direct UV sunlight, heat sources and corrosive chemicals.

PACKAGING
The package contains 2 pieces of chosen size (S, M or L).