FDA 510(k) Application Details - K962743

Device Classification Name Cleanser, Root Canal

  More FDA Info for this Device
510(K) Number K962743
Device Name Cleanser, Root Canal
Applicant PULPDENT CORP.
80 OAKLAND ST.
WATERTOWN, MA 02472 US
Other 510(k) Applications for this Company
Contact KENNETH J BERK
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 07/15/1996
Decision Date 08/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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