Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K120861 |
Device Name |
FIN-S MICROIMPLANT |
Applicant |
CREEKSIDE ORTHODONTICS |
136 E. MALLARD DR. |
BOISE,
ID
83706
|
|
Applicant Contact |
JOHN T KALANGE |
Correspondent |
CREEKSIDE ORTHODONTICS |
136 E. MALLARD DR. |
BOISE,
ID
83706
|
|
Correspondent Contact |
JOHN T KALANGE |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 03/22/2012 |
Decision Date | 02/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|