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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K003518
Device Name RAPIDD HIGHSPEED DENTAL HANDPIECE
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Applicant Contact P. JEFFREY LEHN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK,  PA  17405 -0872
Correspondent Contact P. JEFFREY LEHN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/15/2000
Decision Date 01/09/2001
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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