Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K083543 |
Device Name |
DENOVISMED DENTAL IMPLANT SYSTEMS |
Applicant |
DENOVIS MEDICAL, LLC |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
KEVIN A THOMAS |
Correspondent |
DENOVIS MEDICAL, LLC |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN A THOMAS |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/28/2008 |
Decision Date | 03/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|