FDA 510(k) Application Details - K954281

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K954281
Device Name	Material, Impression
Applicant	ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. ROCHESTER HILLS, MI 48309 US Other 510(k) Applications for this Company
Contact	DON LEROY 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	09/13/1995
Decision Date	06/24/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review