The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Ultrasonic Scaler 3000/ Prophy-jet 30/ Cavi-jet 30.
| Device ID | K864996 |
| 510k Number | K864996 |
| Device Name: | ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTSPLY INTL. CAVITRON PRODUCTS 11-40 BORDEN AVENUE Long Island City, NY 11101 |
| Contact | Harold L Brinkman |
| Correspondent | Harold L Brinkman DENTSPLY INTL. CAVITRON PRODUCTS 11-40 BORDEN AVENUE Long Island City, NY 11101 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-02-19 |