OSSEOSPEED ANGLED ABUTMENT EV


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K121810
Device Name OSSEOSPEED ANGLED ABUTMENT EV
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 872.3630
Classification Product Code
NHA  
Date Received 06/20/2012
Decision Date 01/23/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No