ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K112138
Device Name ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS 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 07/26/2011
Decision Date 12/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No