MOLAR IMPLANT


Device Classification Name

implant, endosseous, root-form

510(k) Number K081128
Device Name MOLAR IMPLANT
Applicant
NOBEL BIOCARE AB
22715 savi ranch parkway
yorba linda, 
CA 
92887

Applicant Contact thuong nguyen son
Correspondent
NOBEL BIOCARE AB
22715 savi ranch parkway
yorba linda, 
CA 
92887

Correspodent Contact thuong nguyen son
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 04/21/2008
Decision Date 11/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No