Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K072363 |
Device Name |
NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX |
Applicant |
BIOMET 3I, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Applicant Contact |
DIANA TAYLOR |
Correspondent |
BIOMET 3I, INC. |
4555 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Correspondent Contact |
DIANA TAYLOR |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 08/23/2007 |
Decision Date | 01/31/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|