Chang Gung ComMed Series Dental Implant System— 510(k) K142751

Name: FDA 510(k) clearance K142751
Creator: U.S. Food and Drug Administration
Published: 2015-06-15

Substantially Equivalent

Chang Gung Medical Technology Co., Ltd.

FDA 510(k) clearance K142751 for Chang Gung ComMed Series Dental Implant System, Substantially Equivalent on 2015-06-15. Applicant: Chang Gung Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chang Gung Medical Technology Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2014-09-24
Decision date: 2015-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

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

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K142982 — OPUS 5100 Diagnostic Doppler Ultrasound System2015-09-03

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.