The following data is part of a premarket notification filed by Innobiosurg Co., Ltd with the FDA for Ibs Implant System.
| Device ID | K140806 |
| 510k Number | K140806 |
| Device Name: | IBS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INNOBIOSURG CO., LTD 12226 WASHINGTON LANE Parker, AZ 85344 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack INNOBIOSURG CO., LTD 12226 WASHINGTON LANE Parker, AZ 85344 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2015-03-23 |