NOBELREPLACE HEXAGONAL IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K073142
Device Name NOBELREPLACE HEXAGONAL IMPLANT
Applicant
NOBEL BIOCARE USA LLC
22715 savi ranch parkway
yorba linda, 
CA 
92887

Applicant Contact kam leung
Correspondent
NOBEL BIOCARE USA LLC
22715 savi ranch parkway
yorba linda, 
CA 
92887

Correspodent Contact kam leung
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 11/07/2007
Decision Date 01/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No