Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K063473 |
Device Name |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
DEBORAH L JACKSON |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
DEBORAH L JACKSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 11/16/2006 |
Decision Date | 03/08/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|