FDA 510(k) Application Details - K090684

Device Classification Name Powder, Porcelain

  More FDA Info for this Device
510(K) Number K090684
Device Name Powder, Porcelain
Applicant SOMERSET DENTAL PRODUCTS, INC.
500 MEMORIAL DRIVE
SOMERSET, NJ 08873 US
Other 510(k) Applications for this Company
Contact CINDY SALTER
Other 510(k) Applications for this Contact
Regulation Number 872.6660

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

  More FDA Info for this Product Code
Date Received 03/16/2009
Decision Date 05/01/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact