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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 K000834
Device Name CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO
Applicant
Castellini S.P.A.
Via Saliceto 22
Castel Maggiore, Bologna,  IT 40013
Applicant Contact GIULIANO LANZARINI
Correspondent
Castellini S.P.A.
Via Saliceto 22
Castel Maggiore, Bologna,  IT 40013
Correspondent Contact GIULIANO LANZARINI
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/14/2000
Decision Date 12/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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