Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K203382 |
Device Name |
Neodent Implant System-Easy Pack |
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 | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/17/2020 |
Decision Date | 03/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|