PROPHY ANGLES, R&R— 510(k) K780199

Substantially Equivalent

Ransom and Randolph

FDA 510(k) clearance K780199 for PROPHY ANGLES, R&R, Substantially Equivalent on 1978-02-16. Applicant: Ransom and Randolph.

Clearance details

Applicant: Ransom and Randolph
Product code: Code EGS
Advisory panel: Dental
Date received: 1978-02-07
Decision date: 1978-02-16
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.