FDA 510(k) Application Details - K003427

Device Classification Name Cement, Dental

  More FDA Info for this Device
510(K) Number K003427
Device Name Cement, Dental
Applicant RITE-DENT MANUFACTURING CORP.
1056 EAST 33RD ST.
HIALEAH, FL 33013-3526 US
Other 510(k) Applications for this Company
Contact CESAR E VELIZ
Other 510(k) Applications for this Contact
Regulation Number 872.3275

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

  More FDA Info for this Product Code
Date Received 11/03/2000
Decision Date 01/24/2001
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



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