FDA 510(k) Application Details - K141576

Device Classification Name Handpiece, Air-Powered, Dental

  More FDA Info for this Device
510(K) Number K141576
Device Name Handpiece, Air-Powered, Dental
Applicant KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA
RUA CHAPECO, 86
SANTA CATARINA BR
Other 510(k) Applications for this Company
Contact MARCOS FERNANDES NUNES
Other 510(k) Applications for this Contact
Regulation Number 872.4200

  More FDA Info for this Regulation Number
Classification Product Code EFB
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/12/2014
Decision Date 05/04/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K141576


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact