ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT


Device Classification Name

abutment, implant, dental, endosseous

510(k) Number K110356
Device Name ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
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 02/07/2011
Decision Date 06/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No