510(k) K020137— AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON

Substantially Equivalent

Aseptico, Inc.

Clearance details

Applicant: Aseptico, Inc.
Product code: Code EGS
Advisory panel: Dental
Date received: 2002-01-16
Decision date: 2002-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

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.