Device Classification Name |
screw, fixation, intraosseous
|
510(k) Number |
K103084 |
Device Name |
NEODENT GRAFT SCREW |
Applicant |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
DAVID J COLLETTE |
Correspondent |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
DAVID J COLLETTE |
Regulation Number | 872.4880
|
Classification Product Code |
|
Date Received | 10/19/2010 |
Decision Date | 02/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|