K121901

Substantially Equivalent

TI-MAX Z45

Applicant: Nakanishi, Inc.
Product code: EGS
Advisory panel: Dental
Date received: 2012-06-29
Decision date: 2013-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bunkyo-Ku, JP

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.