Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K874400 |
Device Name |
NON-ROTATING GOLD CYLINDER AND SCREW |
Applicant |
IMPLANT INNOVATIONS INTERNATIONAL, INC. |
1897 PALM BEACH LAKES BLVD. |
SUITE 114 |
WEST PALM BEACH,
FL
33409
|
|
Applicant Contact |
LAZZARA, DMD |
Correspondent |
IMPLANT INNOVATIONS INTERNATIONAL, INC. |
1897 PALM BEACH LAKES BLVD. |
SUITE 114 |
WEST PALM BEACH,
FL
33409
|
|
Correspondent Contact |
LAZZARA, DMD |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 10/28/1987 |
Decision Date | 03/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|