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Dental Mouthpiece Agreement

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DENTAL MOUTHPIECE AGREEMENT

This Dental Mouthpiece Agreement (the "Agreement") is entered into as of Day: Month: Year: by and between:

WHEREAS

WHEREAS, Provider represents and warrants that Provider is qualified and authorized to design, fabricate and supply custom dental mouthpieces and related services and has the capability to perform the services described in this Agreement; Provider license number:

WHEREAS, Client desires that Provider fabricate a custom dental mouthpiece of the type: for the purpose(s) described: .

WHEREAS, the parties intend that Provider will fabricate the mouthpiece based upon impressions or digital scans taken on date: and that Client will comply with payment and acceptance procedures set forth herein.

SCOPE OF WORK

Provider shall manufacture, fit and deliver a custom dental mouthpiece in accordance with the specifications agreed by the parties. Services include initial consultation, impressions or digital scan processing, laboratory fabrication, clinical fitting, and one follow-up adjustment within the warranty period unless otherwise specified below.

PAYMENT TERMS

The total fee for the Services shall be $ . Client shall pay a non-refundable deposit of $ upon execution of this Agreement. The remaining balance shall be due on or before delivery date or within days of invoice.

Late payments shall incur a late fee of on overdue amounts. Client is responsible for any collection costs, including reasonable attorney's fees, incurred by Provider to collect unpaid amounts.

TERM AND TERMINATION

This Agreement commences on Start Date: and, unless earlier terminated in accordance with this Agreement, continues until End Date: .

Either party may terminate this Agreement for convenience upon providing days' prior written notice. Provider may suspend performance if Client fails to pay any fee when due and may terminate for material breach if such breach is not cured within days after written notice.

CONFIDENTIALITY

Each party agrees to maintain the confidentiality of the other party's confidential information disclosed under this Agreement, including patient health information, treatment records, design specifications and proprietary laboratory processes ("Confidential Information"). Confidential Information shall not be disclosed except to employees, agents or subcontractors with a need to know, and only to the extent necessary to perform the obligations under this Agreement. This obligation does not apply to information that is or becomes publicly available through no breach of this Agreement, or is required to be disclosed by law or court order, provided that the disclosing party gives prompt notice to the other party to permit a protective order or other remedy.

WARRANTIES, REMAKES AND LIMITATION OF LIABILITY

Provider warrants that the mouthpiece will conform to the specifications agreed at delivery and will be free from defects in workmanship for a period of days from delivery. This warranty does not cover damage due to misuse, trauma, lack of follow-up care, or changes in the Client's oral condition.

Remake requests due to Provider error will be performed at no additional charge within the warranty period provided Client returns the mouthpiece and complies with follow-up appointment requests. Remakes required due to changes in Client anatomy or Client error are subject to additional fees as set by Provider.

Except to the extent caused by Provider's gross negligence or willful misconduct, Provider's aggregate liability for any claim arising out of or related to this Agreement shall not exceed the total fees paid by Client under this Agreement. IN NO EVENT SHALL PROVIDER BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES.

DELIVERY, ACCEPTANCE AND ADJUSTMENTS

Provider will use commercially reasonable efforts to deliver the mouthpiece within an estimated days from the date of impressions or scans. Delivery estimates are approximate; Provider shall not be liable for delays caused by laboratory backlogs, material shortages, Client scheduling or other factors beyond Provider's control.

INDEMNIFICATION

Client shall indemnify, defend and hold harmless Provider and its officers, employees and agents from and against any claims, liabilities, costs and expenses (including reasonable attorney's fees) arising from Client's negligence, misuse of the device, failure to follow Provider's instructions, or material false statements made to Provider in connection with treatment.

GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to its conflict of laws principles. Venue for any dispute arising under this Agreement shall be the state or federal courts located in the county where Provider's principal place of business is located.

ENTIRE AGREEMENT

This Agreement, together with any written attachments or treatment plans signed by the parties, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior discussions, negotiations and agreements. Any modification to this Agreement must be in writing and signed by both parties.

CLIENT ACKNOWLEDGMENT

I acknowledge that I have read and understand the terms of this Agreement, that the nature and limitations of the mouthpiece have been explained to me, and that I have had the opportunity to ask questions. I consent to the fabrication and fitting described above.

Contact for notices: Provider Contact: ; Client Contact:

Provider (Print):

By:

Date:

Client (Print):

By:

Date:

Enter text✕

What a Dental Mouthpiece Agreement Covers

A Dental Mouthpiece Agreement is a written contract between a dental practice, a patient, and any third-party dental laboratory or manufacturer responsible for designing, fitting, or fabricating an oral appliance. The agreement defines the device type (night guard, occlusal splint, sports mouthguard, or therapeutic appliance), specifications, materials, service timeline, payment and refund terms, responsibilities for impressions and scans, device adjustments, and limited warranties. It also addresses health and safety disclosures, patient cooperation obligations, retention of clinical records, and assignment of liability between the clinician and the lab for manufacturing defects or improper fit.

Why a Clear Agreement Matters

A written agreement clarifies expectations between patient, clinician, and lab, reduces disputes, and documents consent for fabrication and adjustments.

Why a Clear Agreement Matters

Typical Parties Who Use This Agreement

Dental practices, prosthodontists, dental laboratories, and patients commonly use a Dental Mouthpiece Agreement to document roles and responsibilities before fabrication.

  • Private dental practices and specialists ensuring clear payment, fit, and recall obligations between clinician and patient.
  • Dental laboratories and manufacturers defining manufacturing specs, turnaround time, and liability limitations.
  • Patients consenting to impressions, fees, follow-up adjustments, and sharing medical information for safe device fabrication.

Use a written agreement whenever a custom mouthpiece, splint, or appliance is ordered to create a complete legal and clinical record.

Step-by-Step: Completing the Agreement

Follow this sequence to prepare, review, and finalize the Dental Mouthpiece Agreement quickly and consistently.

  • 01
    Prepare Records: Gather impressions, scans, and clinical notes before drafting.
  • 02
    Specify Device: Choose device type, materials, and measurement tolerances.
  • 03
    Set Terms: Enter price, payment terms, delivery, and warranty.
  • 04
    Sign and Store: Obtain signatures and retain the executed copy securely.

How the Ordering and Approval Flow Typically Works

A standard workflow moves the request from clinician to lab, then back to the clinic and patient for verification and finalization.

  • Order Placement: Clinician uploads prescription and scans to lab.
  • Lab Fabrication: Lab confirms specs and begins manufacturing.
  • Quality Check: Lab inspects device and notifies clinic for pickup.
  • Fitting: Clinic fits device, documents adjustments, and closes the order.

Digital Workflow Settings for Online Completion

Configure your e-workflow to capture required clinical data, signer identity, and an auditable trail for each executed agreement.

Field Configuration
Document Type PDF, DOCX with flattened final copy
Authentication Email link or SMS code for signer verification
Form Fields Signature, Date, Initials, Material checklist
Storage Encrypted archive with retention tag

Technical Requirements for eSubmission and Signing

Ensure the platform supports secure uploads, audit trails, and conditional fields before enabling online signing.

  • Integrations: Salesforce, NetSuite, Google Workspace compatibility
  • File Formats: PDF and DOCX input/output supported
  • Authentication: Email, SMS, or advanced options like KBA

Confirm HIPAA BAA availability when patient health information is included and configure retention policies accordingly.

Essential Clauses to Include in the Agreement

Include discrete sections for scope, materials, responsibilities, payment, warranties, and dispute resolution to reduce ambiguity and legal exposure.

Scope of Work

Clearly describe the device purpose, clinical indications, and any ancillary services such as adjustments, polishing, or relining to avoid scope disputes.

Specifications

State material, thickness, finish, and any manufacturer codes; attach technical drawings or lab prescriptions as exhibits to ensure accurate fabrication.

Turnaround and Delivery

Specify fabrication timeframe, shipping method, and acceptance criteria for delivered items to control timelines and liability for delays.

Payment Terms

Identify fees, payment schedule, who bears shipping costs, and whether refunds or credits apply for remakes or defects.

Warranties and Returns

Limit warranty duration, define defects eligible for remedy, and specify remake procedures to set reasonable expectations.

Liability Allocation

Allocate responsibility between clinician and lab for fit issues, noting that clinical fit problems often require intraoral adjustments by the clinician.

Security and Compliance Items to Address

Encryption in Transit: TLS 1.2/1.3
Encryption at Rest: AES-256 encryption
Audit Trail: Detailed signing history
HIPAA Support: BAA required for PHI
Access Controls: Role-based permissions
Certifications: SOC 2 Type II, ISO 27001

Common Legal Risks and Financial Consequences

Tax Reporting Penalties: 1099 penalties $60–$330 per form
I-9 Violations: $281–$2,789 per violation
HIPAA Breach Risk: Civil penalties and corrective plans
Product Liability: Exposure for harm from defective devices
Contract Disputes: Remedy costs and legal fees
Refund Obligations: Costs to remake or refund device

Frequent Preparation Errors to Avoid

  • Imprecise device specifications that force costly remakes or adjustments by the clinic or lab.
  • Failing to document who pays for shipping, remakes, and adjustments, creating disputes over unexpected charges.
  • Missing patient consent for sharing oral images or scans with third‑party labs, risking privacy and compliance issues.
  • Using vague warranty or return language that fails to define acceptable fit, wear period, or inspection procedure.

Timelines and Deadlines to Document

List concrete deadlines for fabrication, shipping, fitting, and user follow-up to manage expectations and contractual obligations.

Fabrication Turnaround:

Typical 5–14 business days depending on lab capacity

Inspection Window:

Clinic must inspect device within 7 days of receipt

Adjustment Period:

Specify number of complimentary adjustment visits

Remake Request:

Remake must be requested within 30 days of fitting

Warranty Term:

Commonly 90–180 days from delivery

eSignature Vendor Pricing and Feature Snapshot

Comparison of starting prices and core capabilities for common eSignature providers; signNow is listed first per standard vendor ordering.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial No No Yes, limited Yes, limited
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No

Frequently Asked Questions and Troubleshooting

Answers to common questions about validity, signatures, revisions, and storage when using a Dental Mouthpiece Agreement.


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