Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K050506 |
Device Name |
PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS |
Applicant |
LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. |
CHASKA,
MN
55318 -3015
|
|
Applicant Contact |
RACHEL KENNEDY |
Correspondent |
LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. |
CHASKA,
MN
55318 -3015
|
|
Correspondent Contact |
RACHEL KENNEDY |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 02/28/2005 |
Decision Date | 04/15/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|