Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K122664 |
Device Name |
ZUGA DENTAL IMPLANT SYSTEM |
Applicant |
ZUGA MEDICAL, INC. |
P.O. BOX 566 |
CHESTERLAND,
OH
44026 -2141
|
|
Applicant Contact |
KAREN E WARDEN, PHD |
Correspondent |
ZUGA MEDICAL, INC. |
P.O. BOX 566 |
CHESTERLAND,
OH
44026 -2141
|
|
Correspondent Contact |
KAREN E WARDEN, PHD |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/31/2012 |
Decision Date | 04/30/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|