Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K221966 |
Device Name |
Dynamic TiBase |
Applicant |
Talladium Espana, SL |
Virginia Woolf, 17 |
Lleida,
ES
25005
|
|
Applicant Contact |
Xavier Soca Filella |
Correspondent |
PaxMed International, LLC |
12264 EL Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin Thomas |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 07/05/2022 |
Decision Date | 09/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|