The following data is part of a premarket notification filed by Coltene/whaledent with the FDA for Biosonic Suvi Piezeoelectric Scaler And Polisher.
| Device ID | K130137 |
| 510k Number | K130137 |
| Device Name: | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER |
| Classification | Scaler, Ultrasonic |
| Applicant | COLTENE/WHALEDENT 5905 LAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll COLTENE/WHALEDENT 5905 LAWN LANE Cleveland, OH 44141 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-18 |
| Decision Date | 2013-08-23 |
| Summary: | summary |