REPLACE TIUNITE ENDOSSEOUS IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K023113
Device Name REPLACE TIUNITE ENDOSSEOUS IMPLANT
Original Applicant
NOBEL BIOCARE UAS INC
22715 savi ranch pkwy.
yorba linda, 
CA 
92887

Original Contact herbert crane
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 09/19/2002
Decision Date 09/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No