Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K220978 |
Device Name |
TSX Implants |
Applicant |
Biomet 3i LLC |
4555 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Applicant Contact |
Mariela Cabarcas |
Correspondent |
Biomet 3i LLC |
4555 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Correspondent Contact |
Mariela Cabarcas |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 04/04/2022 |
Decision Date | 09/14/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|