8
5. GENERAL SAFETY WITH THE SAPPHIRE
®
PORTABLE DIODE LASER
General Safety Considerations:
Safe use of the Sapphire Portable Diode Laser is the responsibility of the entire dental team including the
doctor, any system operators and the dental office safety officer. Protocols for the safe use of Lasers have been
developed by medical and dental professionals, scientists and laser manufacturers. These protocols should
be followed when using the Sapphire Portable Diode Laser system. Dental professionals have also developed
protocols and guidelines for Laser use on oral soft tissues which should be employed when using the Sapphire
Portable Diode Laser system.
Marketing Requirements Regarding Medical Device Safety (USA):
The United States Food and Drug Administration has control over the sale and use of the all medical devices
including the Sapphire Portable Diode Laser. Manufacturers of products subject to performance standards under
the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control
are required to certify compliance with the regulations and furnish various reports to the Center for Devices and
Radiological Health (CDRH). For manufacturers of medical lasers (such as the Sapphire Portable Diode Laser
system), additional review by the FDA of the safety and effectiveness of the device is required. Companies who
intend to market a medical laser or equivalent device must receive authorization from the FDA before the device
is permitted into commercial distribution. The premarket notification (510(k)) process used for the Sapphire
Portable Diode Laser system is applicable for devices that are documented to be substantially equivalent to
existing legally marketed Class II devices.
Statutory Licensure for Dental Laser use:
Usually, states or provinces do not have a specific licensure requirement for use of surgical Laser devices by
dentists. Many states do, however, require hygienists who will be using Lasers to attend licensure training that
includes both a lecture and hands-on experience. The license applicants are then required to pass a proficiency
test for certification prior to using Lasers. These courses are usually taught by members of the Academy of
Laser Dentistry who possess instructor credentials. Such training would be appropriate for use of the Sapphire
Portable Diode Laser system.
OSHA Provisions:
Worker safety is the responsibility of the employer and is regulated by OSHA (Occupational Safety and Health
Administration), a division of the U.S. Department of Labor. OSHA recognizes ANSI standard Z136.1 as a
source for analyzing safety with respect to medical lasers. For more information see OSHA Technical Manual
(TED 1-0.15A) Section III, Chapter 6, 1999. Den-Mat
®
Holdings, LLC recommends implementation of a safety
program for the safety of your patients and office staff in connection with the use of the Sapphire Portable Diode
Laser. Den-Mat Holdings, LLC also recommends checking and complying with applicable state and provincial
safety and health organization requirements.
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