The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Art-p3ii & P4 Piezo Electric Ultrasonic Scaler Units With Accessories.
| Device ID | K061448 |
| 510k Number | K061448 |
| Device Name: | BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES |
| Classification | Scaler, Ultrasonic |
| Applicant | BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut, CA 91789 |
| Contact | Eric L Ong |
| Correspondent | Eric L Ong BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L 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 | 2006-05-22 |
| Decision Date | 2006-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873120963 | K061448 | 000 |
| 04719873120864 | K061448 | 000 |
| 04719873120734 | K061448 | 000 |
| 04719873120727 | K061448 | 000 |