The following data is part of a premarket notification filed by Bonart Co., Ltd. with the FDA for Oral Surgery System And Accessories.
| Device ID | K152125 |
| 510k Number | K152125 |
| Device Name: | Oral Surgery System And Accessories |
| Classification | Drill, Bone, Powered |
| Applicant | BONART CO., LTD. 4F-1, NO. 3 WUQUAN 1ST RD. Xinzhuang Dist., TW 24892 |
| Contact | Bankson Tsai |
| Correspondent | Eric L. Ong MAGPIE TECH. CORP. 550 YORBITA ROAD La Puente, CA 91744 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2016-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873120611 | K152125 | 000 |
| 04719873120314 | K152125 | 000 |
| 04719873120291 | K152125 | 000 |