Legal Disclaimer

Last Updated: April 20, 2025

Welcome to the official website of ISORetract™, a professional-grade dental retractor system engineered for use in orthodontic and dental procedures.

Please read this Legal Disclaimer carefully. By accessing this website or purchasing the ISORetract™ device, you agree to the terms outlined below.

 

1. General Product Information

ISORetract™ is a reusable dental retraction device designed for use by licensed dental professionals. Its primary purpose is to aid in retracting soft tissues (such as cheeks, lips, and tongue) and to assist with improved visibility, access, and fluid management during dental and orthodontic procedures.

Important: The ISORetract™ device is intended as a clinical support tool and is not marketed as a diagnostic or therapeutic medical device.

2. Regulatory Status

ISORetract™ has been submitted to the U.S. Food and Drug Administration (FDA), and development of the product is proceeding in accordance with applicable regulations. The product is currently undergoing validation testing for sterilization protocols aligned with ISO standards to ensure its suitability for clinical re-use and patient safety.

All sterilization guidance provided at this time is for demonstration purposes only and does not replace formal Instructions for Use (IFU). Official IFU documentation will be made available upon finalization of regulatory and sterilization validation processes.

3. Intended Use and Scope

ISORetract™ is designed exclusively for use by dental professionals during procedures.

  • It supports intraoral visibility, comfort, and chairside efficiency.
  • All usage instructions and product descriptions are based on clinical design input and field experience but are not yet supported by published peer-reviewed studies or third-party comparative testing, unless otherwise noted.

4. Product Development Background

ISORetract™ was developed by a certified orthodontic assistant with over 14 years of hands-on experience in clinical orthodontics. Every design feature has been informed by real-world chairside challenges and refined through professional feedback from practicing orthodontic teams.

Performance claims made on this website reflect internal design goals, practitioner feedback, and usage insight—not independent clinical trials.

5. No Medical Advice

The information presented on this site is for product and educational purposes only. It is not intended to serve as medical advice, diagnosis, or treatment. Always consult with a licensed dental or medical professional for case-specific care or procedural decisions.

6. Limitation of Liability

By using this site or purchasing the ISORetract™ device, you agree that ISORetract™ and its affiliates shall not be liable for any direct or indirect loss, injury, or damage resulting from use or misuse of the product. You assume full responsibility for appropriate sterilization, usage, and clinical oversight within your practice.

7. Intellectual Property

All product designs, brand names, logos, copy, and creative assets featured on this website are the exclusive intellectual property of ISORetract™. Reproduction or unauthorized use of any materials is strictly prohibited without written consent.

8. Updates to This Disclaimer

This disclaimer may be updated periodically to reflect regulatory changes, product development, or business policy. Please check this page regularly for the most current version.

9. Contact Information

If you have any questions regarding this Legal Disclaimer or the ISORetract™ product, please contact us:

ISORetract™ Support
📧 Email: info@isoretract.com
📞 Phone: 385-545-7010
🕘 Hours: Monday – Thursday, 9:00 AM – 5:00 PM MST
📍 Address:
ISORetract™
7533 S Center View Ct, #5033
West Jordan, UT 84084
United States

Acknowledgement

By continuing to use this site or purchasing our product, you acknowledge that you have read, understood, and accepted this Legal Disclaimer in full.