Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K162734 |
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 | 09/30/2016 |
Decision Date | 05/08/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|