Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K003045 |
Device Name |
HA-TI (HAND TITANIUM SCREW) IMPLANT |
Applicant |
HATI DENTAL AG. |
252 W. RIDLEY AVE. |
RIDLEY PARK,
PA
19078
|
|
Applicant Contact |
HEINZ E WICK |
Correspondent |
HATI DENTAL AG. |
252 W. RIDLEY AVE. |
RIDLEY PARK,
PA
19078
|
|
Correspondent Contact |
HEINZ E WICK |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 09/29/2000 |
Decision Date | 07/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|