The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Art-m3ii & M4 Ultrasonic Scaler Units With Accessories (inserts).
| Device ID | K052028 |
| 510k Number | K052028 |
| Device Name: | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) |
| 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 | 2005-07-27 |
| Decision Date | 2005-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873121205 | K052028 | 000 |
| 04719873120581 | K052028 | 000 |
| 04719873120147 | K052028 | 000 |
| 04719873120123 | K052028 | 000 |
| 04719873120109 | K052028 | 000 |
| 04719873120086 | K052028 | 000 |
| 04719873120031 | K052028 | 000 |
| 04719873121397 | K052028 | 000 |
| 04719873121373 | K052028 | 000 |
| 04719873120598 | K052028 | 000 |
| 04719873120673 | K052028 | 000 |
| 04719873121021 | K052028 | 000 |
| 04719873121014 | K052028 | 000 |
| 04719873120970 | K052028 | 000 |
| 04719873120956 | K052028 | 000 |
| 04719873120949 | K052028 | 000 |
| 04719873120703 | K052028 | 000 |
| 04719873120697 | K052028 | 000 |
| 04719873120680 | K052028 | 000 |
| 04719873121540 | K052028 | 000 |