FDA 510(k) Application Details - K961704

Device Classification Name	Splint, Endodontic Stabilizing   More FDA Info for this Device
510(K) Number	K961704
Device Name	Splint, Endodontic Stabilizing
Applicant	DENTATUS USA, LTD. 192 LEXINGTON AVE. NEW YORK, NY 10016 US Other 510(k) Applications for this Company
Contact	STEPHEN B RUBINSKY Other 510(k) Applications for this Contact
Regulation Number	872.3890   More FDA Info for this Regulation Number
Classification Product Code	ELS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/1996
Decision Date	07/26/1996
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