| 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
|
|
| Contact |
betsy a brown |
| Regulation Number | 872.3630
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/07/2011 |
|---|
| Decision Date | 03/01/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Dental
|
|---|
| Review Advisory Committee |
Dental
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
