DENTEC 4000— 510(k) K894930

Substantially Equivalent

Dentec, Inc.

FDA 510(k) clearance K894930 for DENTEC 4000, Substantially Equivalent on 1990-03-27. Applicant: Dentec, Inc..

Clearance details

Applicant: Dentec, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 1989-08-02
Decision date: 1990-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.