Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K130476 |
Device Name |
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE |
Applicant |
DENTAL MORELLI |
18851 NE 29TH AVE 720 |
AVENTURA,
FL
33180
|
|
Applicant Contact |
LILIAN LLULL |
Correspondent |
DENTAL MORELLI |
18851 NE 29TH AVE 720 |
AVENTURA,
FL
33180
|
|
Correspondent Contact |
LILIAN LLULL |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 02/25/2013 |
Decision Date | 01/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|