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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Eraser, Dental Stain
510(k) Number K000140
Device Name CLINI-DENT
Applicant
THE PRECIDENT GROUP
200 WESTPARK CORPORATE CENTER
4364 SOUTH ALSTON AVENUE
DURHAM,  NC  27713 -2280
Applicant Contact WENDY BEDALE
Correspondent
THE PRECIDENT GROUP
200 WESTPARK CORPORATE CENTER
4364 SOUTH ALSTON AVENUE
DURHAM,  NC  27713 -2280
Correspondent Contact WENDY BEDALE
Regulation Number872.6855
Classification Product Code
MAU  
Date Received01/18/2000
Decision Date 05/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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