FDA 510(k) Application Details - K972234

Device Classification Name Syringe, Periodontic, Endodontic, Irrigating

  More FDA Info for this Device
510(K) Number K972234
Device Name Syringe, Periodontic, Endodontic, Irrigating
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK, PA 17405 US
Other 510(k) Applications for this Company
Contact P. JEFFERY LEHN
Other 510(k) Applications for this Contact
Regulation Number 872.4565

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

  More FDA Info for this Product Code
Date Received 06/16/1997
Decision Date 06/30/1997
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