Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K130310 |
Device Name |
CERTAIN BELLATEK PROVISIONAL ABUTMENTS |
Applicant |
BIOMET 3I |
4555 RIVERSIDE DR. |
Palm Bch Gdns,
FL
33410
|
|
Applicant Contact |
JACQUELYN A HUGHES, RAC |
Correspondent |
BIOMET 3I |
4555 RIVERSIDE DR. |
Palm Bch Gdns,
FL
33410
|
|
Correspondent Contact |
JACQUELYN A HUGHES, RAC |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 02/07/2013 |
Decision Date | 06/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|