Regulatory & Compliance Notice

Effective Date: March 20, 2026
Last Updated: August 11, 2026


 

1. Information for Healthcare Professionals

All product information and materials available on this Website are intended solely for licensed dental professionals and individuals engaged in related industries.
This Website is not directed to consumers or patients.


2. Regulatory Status of Products

The regulatory status of HASS products, including approval, clearance, certification, or registration, may vary by country or region.
The inclusion of a product on this Website does not constitute authorization for sale or use in any particular country.
The availability, sale, and distribution of products are subject to the applicable laws and regulatory approvals of each respective jurisdiction.
The supply of any product is strictly subject to regulatory authorization in the relevant country.
Nothing on this Website shall be construed as an offer for sale, solicitation, or promotion of any product in jurisdictions where such sale, distribution, or use is not authorized under applicable law.

 

3. European Union (EU)

Products distributed in the European Union comply with the requirements of Regulation (EU) 2017/745 (MDR). Where applicable, certain products transitionally placed on the market may qualify as Legacy Devices pursuant to Article 120 of Regulation (EU) 2017/745, and continue to be made available strictly in accordance with the extended validity and conditions set out in the said Regulation. The information provided on this website has been prepared in accordance with the intent of Article 7 (Claims) of Regulation (EU) 2017/745. 

4. United States (FDA)

Product information provided in the United States is limited to the scope of the applicable U.S. Food and Drug Administration (FDA) regulatory status of the relevant product, such as clearance or approval, and the requirements associated therewith.
Medical decisions and product use must be based on the approved labeling and Instructions for Use (IFU). The information on this Website does not replace or supersede such approved labeling.
Nothing on this Website shall be interpreted as promoting or recommending use beyond the approved indications (off-label use).


5. Other Countries

In Canada, Japan, Australia, and other jurisdictions, the sale and use of products are subject to the regulatory requirements of the respective country.
Users are responsible for verifying the regulatory approval status of a product prior to use in their jurisdiction.


6. Clinical and Technical Information

Clinical materials, case studies, technical data, and performance information provided on this Website are for general informational purposes only and do not guarantee treatment outcomes for any individual patient. Clinical results may vary depending on individual clinical conditions and professional judgment. Any clinical information presented on this Website is a summary for informational purposes and does not replace full regulatory documentation or approved product labeling. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE U.S. LAW, HASS EXPRESSLY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE CLINICAL EFFICACY, PREDICTABILITY, OR THERAPEUTIC EFFECTIVENESS OF THE PRODUCTS DISPLAYED ON THIS WEBSITE. ALL DECISIONS REGARDING PATIENT CARE MUST REMAIN THE SOLE RESPONSIBILITY OF THE LICENSED HEALTHCARE PROFESSIONAL. 


7. Interpretation of Advertising and Claims

Descriptions, images, videos, and marketing statements used on this Website are intended solely to describe general product characteristics and shall not be interpreted as guaranteeing medical efficacy or treatment outcomes. All content is provided within the limits permitted by applicable regulations of each jurisdiction and shall not be construed as advertising or promotion in countries where such promotion is not permitted. HASS does not make claims that exceed approved labeling, regulatory authorization, or substantiated clinical evidence. Where comparative statements are made, they shall not imply superiority unless supported by appropriate regulatory authorization. All product information on this Website is based on approved Instructions for Use (IFU) and official labeling. In the event of any inconsistency, the approved labeling and IFU shall prevail. HASS IS COMMITTED TO COMPLYING WITH THE FEDERAL TRADE COMMISSION (FTC) ACT AND FDA REGULATORY STANDARDS. ALL OBJECTIVE CLAIMS, STATEMENTS, OR REPRESENTATIONS REGARDING THE SAFETY, PERFORMANCE, OR QUALITY OF HASS PRODUCTS ARE SUBSTANTIATED BY COMPETENT AND RELIABLE SCIENTIFIC EVIDENCE HELD BY HASS PRIOR TO DISSEMINATION. HASS DOES NOT MAKE EXAGGERATED, DECEPTIVE, OR MISLEADING CLAIMS REGARDING ITS PRODUCTS. 


8. Regulatory Changes

Regulatory requirements and product approval status may change in each jurisdiction. HASS reserves the right to modify or update regulatory-related information on this Website. While HASS will make reasonable efforts to reflect significant regulatory updates promptly, such modifications may be implemented without individual prior notice to users. Users are encouraged to verify the latest regulatory updates and verified labeling before relying on the information herein. 

 

9. Investigational or Research Use

Unless explicitly stated otherwise, products presented on this Website are not intended for investigational or experimental use.
Nothing on this Website shall be construed as an offer, proposal, or representation relating to investigational or research-use products.