March 31, 2006
Dear Odyssey Diode Laser Owner: During the design process of the Odyssey Diode laser, our Research and Development staff became very familiar with the various different regulatory and safety requirements associated with the design of a medical laser. This included gaining a thorough understanding of the all of the specific requirements under many laser safety standards and the national regulations in the US, Canada and the European community. As evidenced by our certification through TUV Rheinland of North America, Inc. the laser meets all necessary requirements. In most state or local jurisdictions, there are no additional requirements to using a medical laser, except that it be used by or under the supervision of a licensed medical professional. However, some states and provinces have adopted laws which regulate use of the laser, including requirements for the implementation of particular safety measures by your office. In some instances registration, certification and inspection requirements also apply. As with all other regulations that affect your daily business, your office is responsible for investigating to make sure compliance with these requirements is attained. As a courtesy, and in order to provide the most useful information to our customers, we have compiled the attached list that includes contact information for each State or Provincial government office that oversees, or may oversee regulation of a medical laser. While we have strived to make sure the information is correct, since the regulatory process is ever changing, we cannot assure its complete accuracy. The list should, however, point you in the right direction for your own investigation towards compliance. Should you encounter any problems in the regulatory process or have a question, please feel free to contact me at 716-691-2260. I would be happy to assist you. Thank you for your support of the Odyssey Diode Laser. Very truly yours, IVOCLAR VIVADENT, INC.
Donna Marie Hartnett Director QA/Regulatory Affairs
Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228
Phone: 716-691-0010 Phone: 800-533-6825 Fax: 716-691-2285
www.ivoclarvivadent.us.com mail@ivoclarvivadent.us.com