Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K150012 |
Device Name |
CreoDent Solidex Customized Abutment |
Applicant |
CREODENT PROSTHETICS, LTD. |
29 WEST 30TH STREET, 11TH FLOOR |
NEW YORK,
NY
10001
|
|
Applicant Contact |
CALVIN SHIM |
Correspondent |
CREODENT PROSTHETICS LTD. |
29 WEST 30TH STREET, 11TH FLOOR |
NEW YORK,
NY
10001
|
|
Correspondent Contact |
CALVIN SHIM |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 01/05/2015 |
Decision Date | 06/04/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|