SYNTEC DENTAL IMPLANT— 510(k) K111189

Name: FDA 510(k) clearance K111189
Creator: U.S. Food and Drug Administration
Published: 2012-12-20

Substantially Equivalent

Syntec Scientific Corp.

FDA 510(k) clearance K111189 for SYNTEC DENTAL IMPLANT, Substantially Equivalent on 2012-12-20. Applicant: Syntec Scientific Corp.. Device class: 2.

Clearance details

Applicant: Syntec Scientific Corp.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2011-04-28
Decision date: 2012-12-20
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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K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

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K090839 — MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS2009-04-24
K984602 — SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM1999-03-05

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.