Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K120503 |
Device Name |
CMI IMPLANT IS II ACTIVE |
Applicant |
NEOBIOTECH CO., LTD. |
325 N PUENTE ST. UNIT B |
BREA,
CA
92821
|
|
Applicant Contact |
APRIL LEE |
Correspondent |
NEOBIOTECH CO., LTD. |
325 N PUENTE ST. UNIT B |
BREA,
CA
92821
|
|
Correspondent Contact |
APRIL LEE |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 02/21/2012 |
Decision Date | 06/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|