E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101— 510(k) K051077

Substantially Equivalent

Aseptico, Inc.

FDA 510(k) clearance K051077 for E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101, Substantially Equivalent on 2005-05-03. Applicant: Aseptico, Inc..

Clearance details

Applicant: Aseptico, Inc.
Product code: Code EGS
Advisory panel: Dental
Date received: 2005-04-27
Decision date: 2005-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

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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.