TI-MAX Z45— 510(k) K121901

Name: FDA 510(k) clearance K121901
Creator: U.S. Food and Drug Administration
Published: 2013-02-28

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K121901 for TI-MAX Z45, Substantially Equivalent on 2013-02-28. Applicant: Nakanishi, Inc.. Device class: 1.

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2012-06-29
Decision date: 2013-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bunkyo-Ku, JP

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.