Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K112730 |
Device Name |
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION |
Applicant |
BIOMET 3I |
4555 RIVERSIDE DRIVE |
PALM BEACH GARDENS,
FL
33410
|
|
Applicant Contact |
MAYANK CHOUDHARY |
Correspondent |
BIOMET 3I |
4555 RIVERSIDE DRIVE |
PALM BEACH GARDENS,
FL
33410
|
|
Correspondent Contact |
MAYANK CHOUDHARY |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/20/2011 |
Decision Date | 01/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|