Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K163194 |
Device Name |
Neodent Implant System - GM Line |
Applicant |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA |
AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC |
CURITIBA,
BR
81270-200
|
|
Applicant Contact |
Julianne Lechechem |
Correspondent |
STRAUMANN USA, INC. |
60 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
Jennifer M. Jackson |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/15/2016 |
Decision Date | 07/14/2017 |
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
|
|
|