The following data is part of a premarket notification filed by E.m.s Electro Medical Systems S.a with the FDA for Piezon Built-in Kit, Piezon Built-in Kit Led.
| Device ID | K191079 |
| 510k Number | K191079 |
| Device Name: | Piezon Built-in Kit, Piezon Built-in Kit LED |
| Classification | Scaler, Ultrasonic |
| Applicant | E.M.S Electro Medical Systems S.A Chemin De La Vuarpilliere 31 Nyon, CH Ch-1260 |
| Contact | Suzanne Fassio-hardy |
| Correspondent | Christina Henza Ultra LifeScience Solutions Inc. 872 S. Milwaukee Ave #286 Libertyville, IL 60048 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-23 |
| Decision Date | 2019-08-16 |