The following data is part of a premarket notification filed by Warantec Co., Ltd. with the FDA for Oneplant Dental Implant System.
| Device ID | K081748 |
| 510k Number | K081748 |
| Device Name: | ONEPLANT DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | WARANTEC CO., LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm WARANTEC CO., LTD. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2009-03-27 |
| Summary: | summary |