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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 K141576
Device Name Maxima PRO 45L
Applicant
Kavo DO Brasil Industria E Comercio Ltda
Rua Chapeco, 86
Santa Catarina,  BR
Applicant Contact MARCOS FERNANDES NUNES
Correspondent
Kavo DO Brasil Industria E Comercio Ltda
Rua Chapeco, 86
Santa Catarina,  BR
Correspondent Contact MARCOS FERNANDES NUNES
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/12/2014
Decision Date 05/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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