ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K103759
Device Name ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
Applicant
ASTRA TECH, INC.
8944 tamaroa terr.
skokie, 
IL 
60076

Applicant Contact betsy a brown
Correspondent
ASTRA TECH, INC.
8944 tamaroa terr.
skokie, 
IL 
60076

Correspodent Contact betsy a brown
Regulation Number 872.3630
Classification Product Code
NHA  
Date Received 12/23/2010
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No