The following data is part of a premarket notification filed by Synoross Dba Osseone with the FDA for Osseone Dental Implant System.
| Device ID | K182293 |
| 510k Number | K182293 |
| Device Name: | OsseOne Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Synoross DBA OsseOne 330 N Central Avenue Glendale, CA 91203 |
| Contact | Gennady Shapiro |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030 -0172 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2019-02-15 |
| Summary: | summary |