Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K153624 |
Device Name |
Neodent Implant System |
Applicant |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
AV. JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 - CIC |
CURTIBA,
BR
81270-200
|
|
Applicant Contact |
Jacson Cambruzzi |
Correspondent |
STRAUMANN USA, LLC |
60-100 MINUTEMAN RD |
Andover,
MA
01810
|
|
Correspondent Contact |
Jennifer Jackson |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 12/18/2015 |
Decision Date | 04/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|