OSSEOSPEED NARROW


Device Classification Name

implant, endosseous, root-form

510(k) Number K080396
Device Name OSSEOSPEED NARROW
Applicant
ASTRA TECH AB
11234 el camino real,
suite 200
san diego, 
CA 
92130

Applicant Contact floyd g larson
Correspondent
ASTRA TECH AB
11234 el camino real,
suite 200
san diego, 
CA 
92130

Correspodent Contact floyd g larson
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 02/13/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No