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
|
|
Correspondent Contact |
BETSY A BROWN |
Regulation Number | 872.3630
|
Classification Product Code |
|
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
|
|
|