OSSEOSPEED TM PROFILE SYSTEM


Device Classification Name

implant, endosseous, root-form

510(k) Number K080156
Device Name OSSEOSPEED TM PROFILE SYSTEM
Applicant
ASTRA TECH AB
11234 el camino real,
suite 200
san diego, 
CA 
92130

Applicant Contact linda k schulz
Correspondent
ASTRA TECH AB
11234 el camino real,
suite 200
san diego, 
CA 
92130

Correspodent Contact linda k schulz
Regulation Number 872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received 01/23/2008
Decision Date 09/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No