DENSCO PROPHY ANGLE— 510(k) K821686

Substantially Equivalent

Teledyne Densco

FDA 510(k) clearance K821686 for DENSCO PROPHY ANGLE, Substantially Equivalent on 1982-06-25. Applicant: Teledyne Densco.

Clearance details

Applicant: Teledyne Densco
Product code: Code EGS
Advisory panel: Dental
Date received: 1982-06-08
Decision date: 1982-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.