The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Model Art-p6 Piezo Electric Ultrasonic Scaler & Accessories (tips).
| Device ID | K071981 |
| 510k Number | K071981 |
| Device Name: | BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) |
| 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 | 2007-07-18 |
| Decision Date | 2007-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873121182 | K071981 | 000 |
| 04719873120758 | K071981 | 000 |
| 04719873120659 | K071981 | 000 |
| 04719873120642 | K071981 | 000 |
| 04719873120635 | K071981 | 000 |
| 04719873120628 | K071981 | 000 |
| 04719873120574 | K071981 | 000 |
| 04719873120376 | K071981 | 000 |
| 04719873120369 | K071981 | 000 |
| 04719873120277 | K071981 | 000 |
| 04719873120208 | K071981 | 000 |
| 04719873120192 | K071981 | 000 |
| 04719873120796 | K071981 | 000 |
| 04719873120857 | K071981 | 000 |
| 04719873121151 | K071981 | 000 |
| 04719873121144 | K071981 | 000 |
| 04719873121137 | K071981 | 000 |
| 04719873121120 | K071981 | 000 |
| 04719873121113 | K071981 | 000 |
| 04719873121076 | K071981 | 000 |
| 04719873121052 | K071981 | 000 |
| 04719873121038 | K071981 | 000 |
| 04719873120932 | K071981 | 000 |
| 04719873120925 | K071981 | 000 |
| 04719873120918 | K071981 | 000 |
| 04719873121410 | K071981 | 000 |