Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K191250 |
Device Name |
Southern Implants PEEK Abutments |
Applicant |
Southern Implants (Pty) Ltd |
1 Albert Road |
Irene,
ZA
0062
|
|
Applicant Contact |
Lauranda Breytenbach |
Correspondent |
Southern Implants (Pty) Ltd |
1 Albert Road |
Irene,
ZA
0062
|
|
Correspondent Contact |
Lauranda Breytenbach |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/09/2019 |
Decision Date | 12/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|