The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Art-m3 25k, Model M3-1-art2-a1; Art-m3 30k, Model M3-1-art3-a1.
| Device ID | K994203 |
| 510k Number | K994203 |
| Device Name: | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-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 | 1999-12-13 |
| Decision Date | 2000-03-06 |
| Summary: | summary |