PROPHY PRO.— 510(k) K945834

Name: FDA 510(k) clearance K945834
Creator: U.S. Food and Drug Administration
Published: 1995-02-13

Substantially Equivalent

Hyman, Phelps & McNamara, P.C.

FDA 510(k) clearance K945834 for PROPHY PRO., Substantially Equivalent on 1995-02-13. Applicant: Hyman, Phelps & McNamara, P.C.. Device class: 1.

Clearance details

Applicant: Hyman, Phelps & McNamara, P.C.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1994-11-29
Decision date: 1995-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington Dc, DC, US

Download summary PDF View on FDA.gov ↗

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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.