DENTAURUM CERAMIC DEBONDING UNIT— 510(k) K902018

Substantially Equivalent

Dentauraum, Inc.

FDA 510(k) clearance K902018 for DENTAURUM CERAMIC DEBONDING UNIT, Substantially Equivalent on 1991-04-03. Applicant: Dentauraum, Inc..

Clearance details

Applicant: Dentauraum, Inc.
Product code: Code EKS
Advisory panel: Dental
Date received: 1990-05-03
Decision date: 1991-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

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Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.