OsseOne Dental Implant System— 510(k) K233271

Name: FDA 510(k) clearance K233271
Creator: U.S. Food and Drug Administration
Published: 2025-05-08

Substantially Equivalent

Synoross Dba Osseone

FDA 510(k) clearance K233271 for OsseOne Dental Implant System, Substantially Equivalent on 2025-05-08. Applicant: Synoross Dba Osseone. Device class: 2.

Clearance details

Applicant: Synoross Dba Osseone
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2023-09-29
Decision date: 2025-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Synoross Dba Osseone

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K182293 — OsseOne Dental Implant System2019-02-15

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.