Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K181850 |
Device Name |
Inversa Implants |
Applicant |
Southern Implants (Pty) Ltd |
1 Albert Road |
Irene,
ZA
0062
|
|
Applicant Contact |
Lauranda Breytenbach |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A Thomas |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 07/11/2018 |
Decision Date | 11/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|