FDA 510(k) Application Details - K053065

Device Classification Name Device, Jaw Repositioning

  More FDA Info for this Device
510(K) Number K053065
Device Name Device, Jaw Repositioning
Applicant BRYAN KEROPIAN DDS
18607 VENTURA BLVD., SUITE 206
TARZANA, CA 91356 US
Other 510(k) Applications for this Company
Contact BRYAN KEROPIAN
Other 510(k) Applications for this Contact
Regulation Number 872.5570

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

  More FDA Info for this Product Code
Date Received 11/01/2005
Decision Date 01/03/2006
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