| Device Classification Name |
implant, endosseous, root-form
|
|---|
| 510(K) Number |
K121707 |
|---|
| Model |
2010CO THRU 2017CO, 2510CO THRU 2517CO, 3010CO THRU 3017CO, 2010XO THRU 2017XO, THRU 2517XO, 3010XO THRU 3017XO
|
| Device Name |
LEW MDI O-BALL COLLARED IMPLANT, |
|---|
| Applicant |
| PARK DENTAL RESEARCH CORP. |
| 2401 n commerce st ste b |
|
ardmore,
OK
73401
|
|
| Contact |
ronald bulard |
| Regulation Number | 872.3640
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/11/2012 |
|---|
| Decision Date | 09/24/2012 |
|---|
| 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
|
|---|
|
|
