Legal Disclaimer

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

2. Regulatory Status and Sterilization

ISORetract™ has been developed in accordance with applicable regulatory standards.

• Validated Sterilization Method: Only steam sterilization has been validated.

• Recommended Parameters: 132°C (270°F) for 4 minutes, followed by 30 minutes drying.

• Sterility Assurance Level (SAL): ≤10⁻⁶.

All other sterilization methods, including cold sterilization, have not been validated. Users are advised to follow the validated steam sterilization guidelines. Official Instructions for Use (IFU) will be provided upon finalization of regulatory processes.

3. Intended Use and Scope

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

• Supports intraoral visibility, comfort, and chairside efficiency.

• Usage instructions are based on clinical design input and professional experience.

• The device’s long-term performance is dependent on following validated sterilization procedures and proper use.

4. Product Development Background

ISORetract™ was developed with extensive clinical experience in orthodontics. Every design feature has been informed by real-world chairside challenges and refined through professional feedback from practicing orthodontic teams.

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

5. No Medical Advice

The information on this website is for product and educational purposes only. It is not intended as medical advice. 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 ISORetract™, 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. Users assume full responsibility for appropriate sterilization, usage, and clinical oversight.

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 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

For questions regarding this Legal Disclaimer or ISORetract™:

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

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.