K233271

OsseOne Dental Implant System

510(k) number
K233271
Device name
OsseOne Dental Implant System
Applicant
Synoross Dba Osseone CA · US
Product code
DZE — Implant, Endosseous, Root-Form
Decision date
2025-05-08
Date received
2023-09-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
510(k) Summary (official FDA PDF): K233271.pdf
Official FDA record: K233271
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.