NO FLOSS FLOSSER— 510(k) K854326

Substantially Equivalent

Rgm Assoc.

FDA 510(k) clearance K854326 for NO FLOSS FLOSSER, Substantially Equivalent on 1986-04-23. Applicant: Rgm Assoc..

Clearance details

Applicant: Rgm Assoc.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1985-10-28
Decision date: 1986-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Altos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEQ

product code JEQ

Injury: 188
Malfunction: 2,818
Total: 3,006

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.