Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K211952 |
Device Name |
BTI Interna Narrow/Plus Dental Implant System UnicCa |
Applicant |
B.T.I. Biotechnology Institute, SL |
Leonardo Da Vinci 14, Parque Tecnologico de Alava |
Minano,
ES
01510
|
|
Applicant Contact |
Jose Ramon Rivero |
Correspondent |
B.T.I. Biotechnology Institute, SL |
Leonardo Da Vinci 14, Parque Tecnologico de Alava |
Minano,
ES
01510
|
|
Correspondent Contact |
Jose Ramon Rivero |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/23/2021 |
Decision Date | 07/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|