Device Classification Name |
Scaler, Ultrasonic
|
510(k) Number |
K191079 |
Device Name |
Piezon Built-in Kit, Piezon Built-in Kit LED |
Applicant |
E.M.S Electro Medical Systems S.A |
Chemin de la Vuarpilliere 31 |
Nyon,
CH
CH-1260
|
|
Applicant Contact |
Suzanne Fassio-Hardy |
Correspondent |
Ultra LifeScience Solutions Inc. |
872 S. Milwaukee Ave #286 |
Libertyville,
IL
60048
|
|
Correspondent Contact |
Christina Henza |
Regulation Number | 872.4850
|
Classification Product Code |
|
Date Received | 04/23/2019 |
Decision Date | 08/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|