ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH— 510(k) K941243

Substantially Equivalent

Oraline, Ltd.

FDA 510(k) clearance K941243 for ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH, Substantially Equivalent on 1994-06-06. Applicant: Oraline, Ltd..

Clearance details

Applicant: Oraline, Ltd.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1994-03-15
Decision date: 1994-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, US

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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.