The following data is part of a premarket notification filed by Osteoready Llc with the FDA for Osteoready Dental Implant System.
| Device ID | K173575 |
| 510k Number | K173575 |
| Device Name: | OsteoReady Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OsteoReady LLC 150 Baker Ave. Ext. Ste. 110 Concord, MA 01742 |
| Contact | Robert Gottlander |
| Correspondent | Daniela Levy Sterling Medical Registration 22817 Ventura Blvd Woodland Hills, CA 91364 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-08-17 |
| Summary: | summary |