The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Ultrasonic Scaler, Moedls Art-p3ii Pro And Art-mii Pro.
| Device ID | K081550 |
| 510k Number | K081550 |
| Device Name: | BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO |
| 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 | 2008-06-03 |
| Decision Date | 2008-08-28 |