Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K122300 |
Device Name |
T3 DENTAL IMPLANT |
Applicant |
BIOMET 3I |
4555 RIVERSIDE DR. |
Palm Bch Gdns,
FL
33410
|
|
Applicant Contact |
TAMARA WEST |
Correspondent |
BIOMET 3I |
4555 RIVERSIDE DR. |
Palm Bch Gdns,
FL
33410
|
|
Correspondent Contact |
TAMARA WEST |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 07/31/2012 |
Decision Date | 01/30/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|