The following data is part of a premarket notification filed by Implant Logistics, Inc. with the FDA for Implant-one System.
| Device ID | K173701 |
| 510k Number | K173701 |
| Device Name: | Implant-One System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Implant Logistics, Inc. 3rd Street South La Crosse, WI 54601 |
| Contact | Thomas Arendt |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc. PO Box 566 Chesterland, OH 44026 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-04 |
| Decision Date | 2018-11-29 |
| Summary: | summary |