ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM— 510(k) K901994

Unknown

Rosofsky & Ross, Inc.

FDA 510(k) clearance K901994 for ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM, Unknown on 1990-07-31. Applicant: Rosofsky & Ross, Inc..

Clearance details

Applicant: Rosofsky & Ross, Inc.
Product code: Code EFW
Advisory panel: Dental
Date received: 1990-05-02
Decision date: 1990-07-31
Decision: Unknown
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.