Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K033171 |
Device Name |
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING |
Applicant |
NORTHERN IMPLANTS, LLC |
10565 LEE HIGHWAY |
SUITE 100 |
FAIRFAX,
VA
22030
|
|
Applicant Contact |
GRETA HOLS |
Correspondent |
NORTHERN IMPLANTS, LLC |
10565 LEE HIGHWAY |
SUITE 100 |
FAIRFAX,
VA
22030
|
|
Correspondent Contact |
GRETA HOLS |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 09/30/2003 |
Decision Date | 04/27/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|