FDA 510(k) Application Details - K080479

Device Classification Name Powder, Porcelain

  More FDA Info for this Device
510(K) Number K080479
Device Name Powder, Porcelain
Applicant DMG USA, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
Other 510(k) Applications for this Company
Contact PAMELA PAPINEAU
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 02/22/2008
Decision Date 05/21/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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