Device Classification Name |
file, pulp canal, endodontic
|
510(k) Number |
K892861 |
Device Name |
DENTAL PIK |
Applicant |
U.S. DENTEK CORP. |
32 LEVERONI CT. |
#101 |
NOVATO,
CA
94949
|
|
Applicant Contact |
JOHN M JANSHESKI |
Correspondent |
U.S. DENTEK CORP. |
32 LEVERONI CT. |
#101 |
NOVATO,
CA
94949
|
|
Correspondent Contact |
JOHN M JANSHESKI |
Regulation Number | 872.4565
|
Classification Product Code |
|
Date Received | 04/18/1989 |
Decision Date | 09/15/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|