AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM— 510(k) K130693

Substantially Equivalent

Aseptico, Inc.

FDA 510(k) clearance K130693 for AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM, Substantially Equivalent on 2013-08-14. Applicant: Aseptico, Inc..

Clearance details

Applicant: Aseptico, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 2013-03-14
Decision date: 2013-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.