Device Classification Name |
handpiece, air-powered, dental
|
510(k) Number |
K031145 |
Device Name |
ESTYLUS ELECTRIC MOTOR SYSTEM |
Applicant |
DENTSPLY INTL. |
570 WEST COLLEGE AVE. |
YORK,
PA
17405 -0872
|
|
Applicant Contact |
P. JEFFERY LEHN |
Correspondent |
DENTSPLY INTL. |
570 WEST COLLEGE AVE. |
YORK,
PA
17405 -0872
|
|
Correspondent Contact |
P. JEFFERY LEHN |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 04/10/2003 |
Decision Date | 07/15/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|