HHS NEWS

P97-13                           Food and Drug Administration 

FOR IMMEDIATE RELEASE            Sharon Snider:     301-443-3285

May 7, 1997                      

                                 Consumer Hotline:  800-532-4440  







        FDA CLEARS FIRST LASER FOR TREATING TOOTH DECAY 



     The Food and Drug Administration has cleared for marketing the

first laser system for treating tooth decay.

     The erbium YAG laser system, made by Premier Laser Systems of

Irvine, Calif., was cleared for use directly on teeth.   Lasers

previously have been cleared only for dental use on soft tissue

such as the gums.

     "Use of lasers in dentistry is medicine for the 21st Century. 

They will give dentists and patients a significant new option for

treating decay and doing other related procedures," said Bruce

Burlington, M.D., director of FDA's Center for Devices and

Radiological Health.

     Studies conducted by the manufacturer showed that the laser is



as safe and effective as a high speed drill for removing dental

decay and preparing a cavity for a filling.  The laser is reported

to be noisy, but the noise is different from that of a standard

drill.  The manufacturer's study indicated that fewer patients

needed anesthetic for pain.

                             -More-





                                 Page 2, P97-13, Dental laser



     The laser also was cleared to roughen the enamel, a procedure

used to improve bonding of the restoration.

     The laser system consists of a box-like laser console and a

fiber optic cable with a dental handpiece at the end.  Visually,

the laser handpiece resembles a standard high speed drill.  And

like dental drills, the laser uses water or air to cool the tooth

and clean the surface during removal of decay and cavity treatment.



Dentists and patients will be required to wear goggles during

procedures to protect their eyes.

     The manufacturer conducted two clinical studies in which the

laser was used to treat teeth.  In the first, over 500 teeth with

decay were treated with the laser and later evaluated for damage to

the tooth's nerve and blood supply.  No adverse events were

reported.

     Some 125 patients with decay were enrolled in the second

study.  Half were treated with the laser; the other half were

treated with a high speed drill.  The laser was shown to be as safe

and effective as the drill in removing decay and preparing the

tooth for a filling.

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