The following data is part of a premarket notification filed by Pac-dent International (suzhou), Ltd. with the FDA for Scaletron Piezo Ultrasound Scaler.
| Device ID | K033120 |
| 510k Number | K033120 |
| Device Name: | SCALETRON PIEZO ULTRASOUND SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | PAC-DENT INTERNATIONAL (SUZHOU), LTD. 21078 COMMERCE POINT DR. Walnut, CA 91789 |
| Contact | Daniel Wang |
| Correspondent | Daniel Wang PAC-DENT INTERNATIONAL (SUZHOU), LTD. 21078 COMMERCE POINT DR. Walnut, CA 91789 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-01-29 |
| Summary: | summary |