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RL-OS Oral Positioning Stent

RL-OS Oral Positioning Stent

SKU: RL-OS

Oral positioning stent that stabilizes mouth posture during head & neck radiotherapy.

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Use case
For reproducible oral radiotherapy positioning.
Material
ABS、PCL
Reusability
Single use
Sterilization
EO / single-use

Key advantages

-Reliable Reproducibility – Helps the patient maintain the same mouth opening and bite position at every fraction, reducing setup variability. -Custom Fit in Minutes – The flexible support sleeve is made of polycaprolactone (PCL), a medical-grade thermoplastic that softens in 70–80 °C distilled water within 90 seconds and hardens at body temperature to fit the individual dentition. -Quality Materials – The bite tray frame is made of impact-resistant ABS; the moldable sleeve is PCL, a material with well-documented biocompatibility. -Three Sizes – Available in Large, Medium, and Small to accommodate different oral anatomies. -Single-Patient, Single-Course Use – Each stent set is dedicated to one patient for the duration of a radiotherapy course, supporting cross-infection control protocols.

Product details

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RL-OS Oral Stent

Model: RL-OS
Sizes: L / M / S
Precision Positioning for Confident Radiotherapy

Product Overview

The RL-OS Oral Stent is designed to assist in maintaining a fixed mouth position during oral and head-and-neck radiotherapy. By combining a rigid bite tray frame with a moldable thermoplastic support sleeve, the stent enables reproducible patient positioning, helping to improve treatment accuracy and protect surrounding healthy tissue.

Key Features

  • Reliable Reproducibility – Helps the patient maintain the same mouth opening and bite position at every fraction, reducing setup variability.
  • Custom Fit in Minutes – The flexible support sleeve is made of polycaprolactone (PCL), a medical-grade thermoplastic that softens in 70–80 °C distilled water within 90 seconds and hardens at body temperature to fit the individual dentition.
  • Quality Materials – The bite tray frame is made of impact-resistant ABS; the moldable sleeve is PCL, a material with well-documented biocompatibility.
  • Three Sizes – Available in Large, Medium, and Small to accommodate different oral anatomies.
  • Single-Patient, Single-Course Use – Each stent set is dedicated to one patient for the duration of a radiotherapy course, supporting cross-infection control protocols.

Indications for Use

Intended for use during radiotherapy of the oral cavity, nasopharynx, oropharynx, nasal cavity, and other head-and-neck regions, where a stable and reproducible bite position is required for simulation and treatment delivery.

Instructions for Use

  1. Disinfect – Wipe the bite tray frame with alcohol before initial use.
  2. Soften the Thermoplastic – Place the flexible support sleeve material in a non-stick container and submerge in distilled water at approximately 70–80 °C for 90 seconds, or until fully softened.
  3. Load the Frame – Evenly fill the softened material into the upper and lower grooves of the bite tray frame.
  4. Take the Impression – With the patient lying supine on the base plate, insert the oral stent and instruct the patient to bite down gently for 3–5 minutes, allowing the material to cool and harden.
  5. Ongoing Care – Disinfect with alcohol before and after each use. Do not autoclave or expose to high temperatures.

Contraindications

  • Use with caution in patients with a known history of hypersensitivity or allergic reaction to polymer materials. Clinical evaluation is advised before use.

Warnings and Precautions

  • Do not expose the device to corrosive chemicals or solvents.
  • Handle with care and store properly when not in use.
  • Disinfect with alcohol only. Do not use high-temperature steam or high-pressure sterilization methods.
  • This product is non-sterile.
  • One oral stent set should be used exclusively for one patient’s radiotherapy course.
  • The product must be used under the guidance of qualified medical personnel.
  • Dispose of used products in accordance with applicable local environmental regulations.

Package Contents

  • Bite tray frame × 1
  • Flexible support sleeve (PCL thermoplastic material) × 1 pack
  • Instructions for use × 1

Storage and Transport

Store in a clean, dry, and well-ventilated environment. Keep away from direct sunlight and seal the packaging when not in use. Do not store or transport together with toxic, hazardous, or corrosive materials.

Regulatory Information

  • Medical Device Filing Number: Jin Device Filing No. 20260097
  • Manufacturing Filing Certificate No.: Jin Municipal Drug Administration Device Manufacturing Filing No. 20240028
  • Marketing Authorization Holder / Manufacturer: Tianjin Rongli Electronics Co., Ltd.
  • Address: 1st Floor, Building No. 8, No. 16 Wujing Road, Dongli Economic and Technological Development Zone, Tianjin, China
  • After-Sales Service: Tianjin Rongli Electronics Co., Ltd.
  • Shelf Life: 3 years
  • Date of Issue: July 6, 2026

For product inquiries or procurement, please contact:

Tianjin Rongli Electronics Co., Ltd.
Tel: +86-22-24990355
Reliable positioning consumables for precision radiotherapy.