Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K150669 |
Device Name |
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) |
Applicant |
Neoss Ltd |
Windsor House Cornwall Road |
Harrogate,
GB
Hg1 2PW
|
|
Applicant Contact |
Karin Darle Olsson |
Correspondent |
M SQUARED ASSOCIATES, INC. |
575 8TH AVENUE, SUITE1212 |
NEW YORK,
NY
10018
|
|
Correspondent Contact |
CHERITA JAMES |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/16/2015 |
Decision Date | 10/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|