The following data is part of a premarket notification filed by Dentsply International with the FDA for Bobcat Pro Scaler System, Model G-130.
| Device ID | K033705 |
| 510k Number | K033705 |
| Device Name: | BOBCAT PRO SCALER SYSTEM, MODEL G-130 |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17404 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17404 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2003-12-04 |
| Summary: | summary |