Dental Appliances | Terms and ConditionsSerena Sleep

Effective Date: March 5, 2026

These Terms and Conditions of Sale (“Terms”) apply to all sales of dental appliances for sleep apnea treatment, night guards, orthotics, and associated products (“Products”) by Serena Sleep Solutions (“Serena,” “we,” “us,” or “our”), located at 592 Outpost Circle, Hudson, WI 55043, to licensed dentists, medical professionals, or their authorized practices (“Buyer” or “you”). Serena sells exclusively to qualified professionals and does not offer Products directly to consumers. By submitting an order or purchasing Products, you acknowledge that you have read, understood, and agreed to these Terms, which override any conflicting provisions in your documents unless we specifically accept them in writing. We may revise these Terms periodically; the latest version will be posted on our website (www.serenasleep.com), and your continued purchases signify acceptance of updates.

Scope and Professional Relationship
Order Placement and Confirmation
Pricing, Invoicing, and Payment
Delivery, Risk Transfer, and Inspection
Compliance with Laws and Professional Duties
Product Warranties
Returns, Exchanges, and Adjustments
Liability Restrictions
Your Indemnity Obligations
Ownership of Intellectual Property
Handling of Confidential Information
Unforeseeable Events
Law Governing and Resolution of Disputes
Website Use and Advertising Disclaimers
Electronic Communications and Signatures
Privacy and Data Protection
Additional Provisions

1. Scope and Professional Relationship

These Terms cover all aspects of our business dealings, including order placement, manufacturing, delivery, and post-sale support. As a manufacturer of custom dental devices, we rely on your professional expertise for patient assessments, prescriptions, and fittings. You confirm that you are a licensed healthcare provider in good standing, authorized to prescribe and dispense our Products in your practice’s jurisdiction. We do not provide medical advice, diagnose conditions, or assume liability for treatment outcomes, which remain your sole responsibility.

2. Order Placement and Confirmation

Orders must be submitted through our secure online system, email, or fax, including precise patient details such as impressions, scans, models, bite registrations, and prescriptions. We review orders for completeness and may request clarifications. Submission does not obligate us to accept the order; we may decline it for reasons including incomplete information, credit issues, or compliance concerns.

Upon acceptance, we issue a confirmation via email, which forms the binding agreement. Custom manufacturing begins promptly after confirmation. Changes or cancellations require our written approval and may result in fees covering costs incurred, up to the full order amount if production is already advanced. We aim to fulfill orders within standard lead times, but delays do not entitle you to cancel the order without our consent.

3. Pricing, Invoicing, and Payment

Prices are as quoted or listed in our current catalog and exclude taxes, shipping, insurance, or customs fees, which remain your responsibility. We may adjust prices with notice, but not for confirmed orders. Invoices are issued upon shipment and are payable within 30 days net unless we specify different terms based on your credit status.

Acceptable payment methods include bank transfer, credit card, or check. Late payments incur a finance charge of 1.5% per month (or the legal maximum) on overdue balances. We may withhold future deliveries or require advance payment if accounts are delinquent. No deductions for disputes are allowed without our prior authorization. Bona fide disputes must be raised in writing within 15 days of invoice receipt, and we will negotiate resolution in good faith.

Credit extensions are subject to approval after review of your application. We may perform credit checks and adjust terms as necessary.

4. Delivery, Risk Transfer, and Inspection

Products ship from our Hudson, WI facility via a carrier of our choice, FOB origin. Title and risk of loss pass to you when the Products leave our premises. You are responsible for shipping costs and any insurance. Delivery timelines are estimates only, and we are not liable for carrier delays or related damages.

You must examine shipments immediately upon arrival and report any visible damage, shortages, or errors in writing within 5 business days. Failure to notify us within this timeframe waives any claims. For concealed defects, you must notify us within 10 days of discovery, but no later than the end of the warranty period.

5. Compliance with Laws and Professional Duties

Our Products are Class II medical devices under FDA regulations. We manufacture them in compliance with 21 CFR Part 820 (Quality System Regulation) and maintain the required regulatory clearances. You are responsible for complying with all federal, state, and local laws, including but not limited to prescription requirements, patient consent, adverse event reporting under 21 CFR Part 803, and HIPAA requirements for data privacy.

You warrant that you hold valid licenses and registrations, that you will dispense Products only to patients under your professional care with proper documentation, that you will report any Product-related incidents or complaints to us within 48 hours, and that you will not export, resell online, or distribute the Products outside your licensed area without our approval. Violations may void warranties and terminate our professional relationship.

6. Product Warranties

Product warranties must be processed through the healthcare professional. Serena Sleep warrants its nightguard and orthotic appliances to be free from defects in materials and fabrication for a period of 12 months from the date of delivery to the providing practitioner. These devices are designed to protect teeth and restorations against the forces of bruxism and to help alleviate temporomandibular joint pain, jaw discomfort, muscle strain, and tension headaches. However, Serena Sleep does not guarantee treatment outcomes. The warranty is invalid if the appliance needs to be remade due to changes in the patient’s oral anatomy or if the appliance is broken, cracked, or worn through by the patient. The warranty does not cover improper cleaning, unauthorized modifications, accessory components, or other non-manufacturing related issues.

Serena Sleep also provides a 3-year warranty for sleep appliances used to treat snoring and obstructive sleep apnea. This warranty guarantees that the appliance will be free from defects in materials and fabrication for 36 months from the delivery date to the practitioner. Serena Sleep does not guarantee the outcome of obstructive sleep apnea treatment. The warranty becomes invalid if the appliance requires remaking due to changes in the patient’s oral anatomy or if the appliance is damaged beyond repair by the patient. Accessory parts such as straps, hinges, and elastics, as well as bite registration changes, improper cleaning, unauthorized modifications, or other non-manufacturing issues, are not covered.

7. Returns, Exchanges, and Adjustments

All product returns or remakes must be processed through the healthcare professional. Custom products are non-returnable except when covered under warranty. If a remake or return is required, you must contact us first for instructions. Products must be shipped prepaid for evaluation. If the issue is covered under warranty, we will proceed accordingly. Repairs that are not covered under warranty will be billed at the prevailing service rates.

8. Liability Restrictions

Our total liability for any claim, whether in contract, tort, or otherwise, is limited to the purchase price of the Product, to the maximum extent permitted by applicable law. We are not responsible for indirect, consequential, incidental, special, or punitive damages, including but not limited to lost revenue, medical costs, or reputational harm, even if such damages were foreseeable.

These limitations apply regardless of the failure of any remedy’s essential purpose. Some states do not allow the exclusion or limitation of incidental or consequential damages, so these limitations may not apply in those jurisdictions.

9. Your Indemnity Obligations

You agree to defend, indemnify, and hold us harmless, including our affiliates, employees, and agents, from any claims, damages, losses, or expenses, including legal fees, arising from your negligent or improper use or fitting of Products, inaccurate prescriptions or patient data, regulatory violations, patient disputes related to your professional services, or breaches of these Terms.

You must provide prompt notice of any claim. We reserve the right to participate in the defense at our own cost. No settlement that affects us may be entered into without our prior written approval.

10. Ownership of Intellectual Property

All rights related to our designs, trademarks, patents, copyrights, and proprietary know-how remain exclusively ours. Purchasing our Products does not transfer ownership or grant any license beyond their professional use in patient care. You may not copy, reverse engineer, disassemble, or commercialize our products or technology. You agree to notify us if you become aware of any potential intellectual property infringement.

11. Handling of Confidential Information

During our professional relationship, you may gain access to confidential or proprietary information such as formulas, pricing structures, or technical details. You must treat this information as confidential and use it solely for purposes related to order fulfillment. You must also take reasonable steps to prevent unauthorized disclosure. Upon request or termination of the relationship, such information must be returned or destroyed.

We also protect patient data you provide in accordance with applicable privacy laws and use it solely for manufacturing, compliance, and service purposes. Confidentiality obligations remain in effect for seven years following termination of the relationship.

12. Unforeseeable Events

Neither party will be liable for failure or delay in performance caused by events beyond reasonable control, including natural disasters, supply chain disruptions, labor disputes, or government actions. The affected party must promptly notify the other party, and obligations will resume once conditions allow. If delays extend beyond 60 days, either party may terminate the affected orders without penalty.

13. Law Governing and Resolution of Disputes

These Terms are governed by the laws of the State of Wisconsin, without regard to conflict-of-law principles. Any disputes must be resolved exclusively in the state or federal courts located in St. Croix County, Wisconsin, and you consent to their jurisdiction and waive any objections to venue.

14. Website Use and Advertising Disclaimers

Our website, www.serenasleep.com, is provided for informational purposes and is intended only for licensed healthcare professionals. By accessing or using the website, you agree to these Terms. We grant you a limited, non-exclusive, and revocable license to view and download content for professional use, provided that you do not modify, reproduce, distribute, or create derivative works without written permission.

All website content, including text, images, logos, and other materials, is owned by us or our licensors and protected by intellectual property laws. Unauthorized use may violate these laws and result in termination of access.

Information on the website, including product descriptions and educational materials, is general in nature and is not intended to provide medical advice or replace professional judgment. We make no warranties regarding the accuracy, completeness, or suitability of website content and disclaim all warranties, including merchantability and fitness for a particular purpose, to the maximum extent permitted by law.

Advertising materials follow FDA and FTC guidelines for medical devices and are based on available data. They are not intended to promote off-label uses. You are responsible for ensuring that your own marketing activities comply with applicable laws. We are not liable for reliance on website information that results in damages or claims.

15. Electronic Communications and Signatures

By using our services or website, you consent to receiving electronic communications such as emails, notices, and disclosures. You agree that electronic signatures, records, and contracts carry the same legal effect as paper documents, in accordance with the Electronic Signatures in Global and National Commerce Act (E-SIGN), the Uniform Electronic Transactions Act (UETA), and applicable state laws.

16. Privacy and Data Protection

We collect and process personal information, including patient data you provide, according to our Privacy Policy available at www.serenasleep.com/privacy. This policy is incorporated into these Terms. We comply with HIPAA and applicable state privacy laws when handling protected health information. You confirm that you have obtained all necessary patient consents before sharing such data with us.

17. Additional Provisions

If any provision of these Terms is found to be invalid or unenforceable under applicable law, it will be modified or removed only to the extent necessary, while the remaining provisions remain fully enforceable. Any delay in enforcing a provision does not constitute a waiver of rights. You may not assign your rights or obligations under these Terms without our consent, although we may assign them freely.

These Terms, together with confirmed orders, constitute the entire agreement between the parties and replace all prior understandings. Official notices must be sent to our Hudson address or the last contact information provided by you and will be considered effective upon receipt. Provisions related to liability limitations, indemnity, intellectual property, confidentiality, and dispute resolution will survive termination of the agreement.

For questions, please contact us at 592 Outpost Circle, Hudson, WI 55043 or via email at info@serenasleep.com.

Terms and Conditions of Sale for Serena Sleep Solutions