The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Art-m1, Model M1-1-art-a1.
| Device ID | K000510 |
| 510k Number | K000510 |
| Device Name: | ART-M1, MODEL M1-1-ART-A1 |
| Classification | Scaler, Ultrasonic |
| Applicant | BONART CO. LTD. RM. 405, NO.3 WUCHUAN 1ST ROAD Hsinchuang, Taipei, TW |
| Contact | Bankson Tsai |
| Correspondent | Bankson Tsai BONART CO. LTD. RM. 405, NO.3 WUCHUAN 1ST ROAD Hsinchuang, Taipei, TW |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873120871 | K000510 | 000 |
| 04719873121366 | K000510 | 000 |
| 04719873121380 | K000510 | 000 |
| 04719873120024 | K000510 | 000 |
| 04719873120079 | K000510 | 000 |
| 04719873120093 | K000510 | 000 |
| 04719873120116 | K000510 | 000 |
| 04719873120130 | K000510 | 000 |
| 04719873120154 | K000510 | 000 |
| 04719873120741 | K000510 | 000 |
| 04719873120765 | K000510 | 000 |
| 04719873120772 | K000510 | 000 |
| 04719873121533 | K000510 | 000 |