Device Classification Name |
Implant, Endosseous, Orthodontic
|
510(k) Number |
K062732 |
Device Name |
TOMAS PIN 6 MM |
Applicant |
DENTAURUM |
10 PHEASANT RUN |
NEWTOWN,
PA
18940
|
|
Applicant Contact |
CHARLES R BELL |
Correspondent |
DENTAURUM |
10 PHEASANT RUN |
NEWTOWN,
PA
18940
|
|
Correspondent Contact |
CHARLES R BELL |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 09/13/2006 |
Decision Date | 10/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|