Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K101890 |
Device Name |
BALL ABUTMENT SYSTEM |
Applicant |
MEGAGEN CO., LTD. |
325 N. PUENTE STREET |
UNIT B |
BREA,
CA
92821
|
|
Applicant Contact |
JOYCE BANG |
Correspondent |
MEGAGEN CO., LTD. |
325 N. PUENTE STREET |
UNIT B |
BREA,
CA
92821
|
|
Correspondent Contact |
JOYCE BANG |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/07/2010 |
Decision Date | 02/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|