Class Class II
OsseOne Dental Implant System (K233271)
Description
OsseOne Dental Implant System by Synoross Dba Osseone, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233271
Clearance Date2025-05-08
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233271
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. OsseOne Dental Implant System (K233271) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | 2024 |
| K182615 | Surgikor Dental Implant System | Surgikor, LLC | 2019 |
| K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | 2019 |
Trace the full predicate network for K233271
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.