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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D661600196080 | K130137 | 000 |
| D661600142840 | K130137 | 000 |
| D661600142810 | K130137 | 000 |
| D661600142780 | K130137 | 000 |
| D661600142750 | K130137 | 000 |
| D661600142690 | K130137 | 000 |
| D661600142670 | K130137 | 000 |
| D661600142660 | K130137 | 000 |
| D661600142620 | K130137 | 000 |
| D661600142610 | K130137 | 000 |
| D661600142600 | K130137 | 000 |
| D661600142590 | K130137 | 000 |
| D661600142400 | K130137 | 000 |
| D661600142390 | K130137 | 000 |
| D661600142380 | K130137 | 000 |
| D661600142850 | K130137 | 000 |
| D661600142860 | K130137 | 000 |
| D661600193280 | K130137 | 000 |
| D661600187660 | K130137 | 000 |
| D661600187630 | K130137 | 000 |
| D661600184860 | K130137 | 000 |
| D661600184850 | K130137 | 000 |
| D661600144570 | K130137 | 000 |
| D661600144560 | K130137 | 000 |
| D661600144550 | K130137 | 000 |
| D661600144540 | K130137 | 000 |
| D661600143110 | K130137 | 000 |
| D661600143090 | K130137 | 000 |
| D661600143070 | K130137 | 000 |
| D661600143030 | K130137 | 000 |
| D661600142870 | K130137 | 000 |
| D661600142370 | K130137 | 000 |