SM IMPLANT SYSTEMS— 510(k) K061797

Name: FDA 510(k) clearance K061797
Creator: U.S. Food and Drug Administration
Published: 2006-09-01

Substantially Equivalent

Dio Department Dsi, Inc.

FDA 510(k) clearance K061797 for SM IMPLANT SYSTEMS, Substantially Equivalent on 2006-09-01. Applicant: Dio Department Dsi, Inc.. Device class: 2.

Clearance details

Applicant: Dio Department Dsi, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2006-06-26
Decision date: 2006-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, 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 Dio Department Dsi, Inc.

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K080129 — SECURE IMPLANT SYSTEM (2.5/3.0MM)2008-05-30
K073070 — DIO BIOTITE-H IMPLANT SYSTEM2008-05-16
K080128 — SM-EXTRA WIDE (RBM) IMPLANT SYSTEM2008-05-14
K070570 — DIO IMPLANT SYSTEM2008-04-15
K080126 — DIO PROTEM IMPLANT SYSTEM2008-04-11

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.