Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K113003 |
Device Name |
ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... |
Applicant |
ASTRA TECH INC. |
8944 TAMAROA TERRACE |
SKOKIE,
IL
60076
|
|
Applicant Contact |
BETSY A BROWN |
Correspondent |
ASTRA TECH INC. |
8944 TAMAROA TERRACE |
SKOKIE,
IL
60076
|
|
Correspondent Contact |
BETSY A BROWN |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/07/2011 |
Decision Date | 03/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|