The following data is part of a premarket notification filed by Bonart Co., Ltd. with the FDA for Bonart Dental Handpieces (art), Disposable Prophy Angle (proformance).
| Device ID | K162856 |
| 510k Number | K162856 |
| Device Name: | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | Bonart Co., Ltd. NO. 80, WUXUAN ST., Keelung City, TW 20446 |
| Contact | Bankson Tsai |
| Correspondent | Eric L. Ong Magpie Tech. Corp. 550 Yorbita Road La Puente, CA 91744 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-12 |
| Decision Date | 2017-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873121090 | K162856 | 000 |
| 04719873121083 | K162856 | 000 |
| 04719873120666 | K162856 | 000 |
| 04719873120215 | K162856 | 000 |