Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K122231 |
Device Name |
XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM |
Applicant |
MEGAGEN IMPLANT CO., LTD |
325 N PUENTE ST. UNIT B |
BREA,
CA
92821
|
|
Applicant Contact |
APRIL LEE |
Correspondent |
MEGAGEN IMPLANT CO., LTD |
325 N PUENTE ST. UNIT B |
BREA,
CA
92821
|
|
Correspondent Contact |
APRIL LEE |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/26/2012 |
Decision Date | 10/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|