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Intended as an aid in the reduction of snoring for adults at least 18 years old.

The QuietLab Pro Anti-Snoring Mouthpiece is a reusable, over-the-counter oral appliance intended to reduce or eliminate snoring by gently repositioning the lower jaw to maintain an open upper airway during sleep. The device achieves this effect through a precision-adjustable mandibular advancement mechanism that minimizes airway collapse and reduces tissue vibration—the primary cause of snoring.

Scientific Basis and Mechanism of Action:
Snoring typically occurs when the muscles around the throat relax during sleep—especially during REM—causing a partial collapse of the airway. As air moves through this narrowed passage, it vibrates the soft tissues, producing the characteristic sound of snoring. The QuietLab Pro addresses this by:

• Advancing the lower jaw (mandible) slightly forward using a precision-fit tray and hinge system.
• Increasing pharyngeal space to prevent airway collapse.
• Promoting steady airflow and reducing soft tissue vibration during sleep.

Device Design and Key Performance Characteristics:
The QuietLab Pro is comprised of three primary components, designed for comfort, adjustability, and durability:

1. Central Part - Structural Component

• Thermoplastic Polyurethane for flexible hinge zones.
• Provides structural support, maintains upper/lower tray alignment, and enables lateral jaw movement during sleep.

2. Central Part – Hard Inserts & Attachment Pins (4-Pin Diamond-Shaped Sliding Mechanism)

• Made of Polycarbonate (PC) for rigidity
• Offers incremental, repeatable adjustment to tailor the mandibular position to the user's anatomy.
• Prevents unintentional shifting during use, improving comfort and treatment consistency.

3. Upper and Lower Trays (Anatomical Trays)

• Fabricated from Thermoplastic Elastomer
• Anatomically contoured to fit over dental arches without molding.
• The lower tray allows for up to 9 mm of mandibular advancement via a 25-position micro-adjustment system.

Material Composition:
All components are made of biocompatible, medical-grade materials tested for prolonged mucosal contact (per ISO 10993-1):

• PC (Polycarbonate) – Provides strength and stability.
• TPU (Thermoplastic Polyurethane) – Allows for flexibility at hinge and contact points.
• TPE (Thermoplastic Elastomer) – Ensures soft tissue compatibility and user comfort.

The device is manufactured in an ISO-certified facility under strict quality controls and is compliant with RoHS material safety standards.

The carrying-case material is indirect patient contact only.

Physical Properties:

• Non-sterile, reusable device intended for single-patient use.
• Designed for home use during sleep.
• Accommodates diverse dental anatomies through flexible materials and an Adaptive Fit system.
• Lightweight, with integrated grooves to promote airflow and minimize saliva buildup.

Function and Adjustability:

• Upper Tray: Provides upper jaw stabilization.
• Lower Tray: Delivers adjustable mandibular advancement.
• Adjustment Range: Up to 9 mm total advancement with fine control.
• Custom Fit: No boiling or molding required; adjustment is tool-free and user-controlled.

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