The following data is part of a premarket notification filed by Advanced Medical Devices, Inc. with the FDA for Piezo Tronic.
| Device ID | K982793 |
| 510k Number | K982793 |
| Device Name: | PIEZO TRONIC |
| Classification | Scaler, Ultrasonic |
| Applicant | ADVANCED MEDICAL DEVICES, INC. 3722 AVE SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland ADVANCED MEDICAL DEVICES, INC. 3722 AVE SAUSALITO Irvine, CA 92606 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1998-10-28 |
| Summary: | summary |