HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM— 510(k) K130221

Name: FDA 510(k) clearance K130221
Creator: U.S. Food and Drug Administration
Published: 2013-03-21

Substantially Equivalent

Medimecca Co., Ltd.

FDA 510(k) clearance K130221 for HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2013-03-21. Applicant: Medimecca Co., Ltd.. Device class: 2.

Clearance details

Applicant: Medimecca Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2013-01-29
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

view all

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 Medimecca Co., Ltd.

view all

K202039 — Honorst Implant System2020-09-25
K160536 — Chaorum Implant System2017-01-05
K131682 — UD IMPLANT SYSTEM2013-12-05

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.