Device Classification Name |
scaler, ultrasonic
|
510(k) Number |
K010195 |
Device Name |
PREMIER ULTRASONIC SCALER AND INSERTS |
Applicant |
PREMIER DENTAL PRODUCTS CO. |
3600 HORIZON DR. |
P.O. BOX 61574 |
KING OF PRUSSIA,
PA
19406
|
|
Applicant Contact |
WILLIAN FREZEL |
Correspondent |
PREMIER DENTAL PRODUCTS CO. |
3600 HORIZON DR. |
P.O. BOX 61574 |
KING OF PRUSSIA,
PA
19406
|
|
Correspondent Contact |
WILLIAN FREZEL |
Regulation Number | 872.4850
|
Classification Product Code |
|
Date Received | 01/22/2001 |
Decision Date | 04/17/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|