Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K203542 |
Device Name |
Neodent Implant System - Mini Abutment 60° |
Applicant |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Av. Juscelino Kubitschek de Oliveira, 3291- CIC |
Curitiba,
BR
81270-200
|
|
Applicant Contact |
Mariana Soares Hartmann |
Correspondent |
Straumann USA, LLC |
60 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Jennifer M Jackson |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 12/03/2020 |
Decision Date | 08/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|