FDA 510(k) Application Details - K000983

Device Classification Name Powder, Porcelain

  More FDA Info for this Device
510(K) Number K000983
Device Name Powder, Porcelain
Applicant C-MIX
3234 ELLA LN.
NEW PORT RICHEY, FL 34655 US
Other 510(k) Applications for this Company
Contact ART WARD
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 03/27/2000
Decision Date 08/26/2000
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



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