INTERMEZZO PLUS FIXTURE— 510(k) K053354

Name: FDA 510(k) clearance K053354
Creator: U.S. Food and Drug Administration
Published: 2006-04-13

Substantially Equivalent

Megagen Co., Ltd.

FDA 510(k) clearance K053354 for INTERMEZZO PLUS FIXTURE, Substantially Equivalent on 2006-04-13. Applicant: Megagen Co., Ltd.. Device class: 2.

Clearance details

Applicant: Megagen Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2005-12-02
Decision date: 2006-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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K260006 — INOSS System2026-06-17

More clearances from Megagen Co., Ltd.

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K110955 — ANYRIDGE INTERNAL IMPLANT SYSTEM2011-11-22
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K073058 — RESCUE INTERNAL IMPLANT SYSTEM2008-04-11
K070562 — EZ PLUS IMPLANT SYSTEM2007-05-18
K063216 — RESCUE INTERNAL IMPLANT SYSTEM2007-04-02

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.