REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE


Device Classification Name

implant, endosseous, root-form

510(k) Number K023952
Device Name REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
Original Applicant
NOBEL BIOCARE UAS INC
22715 savi ranch pkwy.
yorba linda, 
CA 
92887

Original Contact katheleen dragovich
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 11/27/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No