FDA 510(k) Application Details - K141092

Device Classification Name Material, Impression

  More FDA Info for this Device
510(K) Number K141092
Device Name Material, Impression
Applicant CAVEX HOLLAND B.V
P.O. BOX 852
HAARLEM 2031 WH NL
Other 510(k) Applications for this Company
Contact R, WOORTMAN
Other 510(k) Applications for this Contact
Regulation Number 872.3660

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

  More FDA Info for this Product Code
Date Received 04/28/2014
Decision Date 12/04/2014
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



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