LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)— 510(k) K042345

Name: FDA 510(k) clearance K042345
Creator: U.S. Food and Drug Administration
Published: 2005-01-13

Substantially Equivalent

Mondeal Medical Systems GmbH

FDA 510(k) clearance K042345 for LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS), Substantially Equivalent on 2005-01-13. Applicant: Mondeal Medical Systems GmbH. Device class: 2.

Clearance details

Applicant: Mondeal Medical Systems GmbH
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2004-08-30
Decision date: 2005-01-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

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K260006 — INOSS System2026-06-17

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K062436 — SIS SINUS IMPLANT STABILIZER2007-07-30
K050257 — LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)2005-02-07

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.