Regulatory & Compliance Notice

Effective Date: March 20, 2026
Last Updated: March 20, 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, where applicable, with the requirements of Directive 93/42/EEC (MDD) or Regulation (EU) 2017/745 (MDR).
Certain products may qualify as Legacy Devices pursuant to Article 120 of Regulation (EU) 2017/745, and may continue to be placed on the market in accordance with the conditions set out in the 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.

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 does not make exaggerated or misleading claims regarding the safety, performance, or therapeutic effectiveness of 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 without prior notice.

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.