ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH— 510(k) K936076

Substantially Equivalent

Ohio Health Care Products, Inc.

FDA 510(k) clearance K936076 for ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH, Substantially Equivalent on 1994-01-26. Applicant: Ohio Health Care Products, Inc..

Clearance details

Applicant
Ohio Health Care Products, Inc.
Product code
Code JEQ
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Manassas, VA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JEQ

product code JEQ
Injury
188
Malfunction
2,818
Total
3,006

Source: openFDA MAUDE database, through . 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.