Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K173902 |
Device Name |
Neodent Implant System – GM Line |
Applicant |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC |
Curitiba,
BR
81270-200
|
|
Applicant Contact |
Julianne de Oliveira Capucho Lechechem |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A. Thomas |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 12/22/2017 |
Decision Date | 04/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|