Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K945848 |
Device Name |
FRIALIT(R)-2 DENTAL IMPLANT |
Applicant |
FRIATEC MEDICAL INC., USA |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
ROBERT J SLOMOFF |
Correspondent |
FRIATEC MEDICAL INC., USA |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
ROBERT J SLOMOFF |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 11/30/1994 |
Decision Date | 03/15/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|