FDA 510(k) Application Details - K100633

Device Classification Name Implant, Endosseous, Orthodontic

  More FDA Info for this Device
510(K) Number K100633
Device Name Implant, Endosseous, Orthodontic
Applicant D B ORTHODONTICS LTD
RYEFIELD WAY
SILSDEN, KEIGHLEY
WEST YORKSHIRE BD20 OEF GB
Other 510(k) Applications for this Company
Contact ANNA DYSON
Other 510(k) Applications for this Contact
Regulation Number 872.3640

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

  More FDA Info for this Product Code
Date Received 03/05/2010
Decision Date 04/01/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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