FDA 510(k) Application Details - K984037

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K984037
Device Name	Coating, Filling Material, Resin
Applicant	ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. ROCHESTER HILLS, MI 48309 US Other 510(k) Applications for this Company
Contact	DONALD A LEROY Other 510(k) Applications for this Contact
Regulation Number	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1998
Decision Date	02/04/1999
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