Clearance Summary
ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM received FDA 510(k) clearance under submission number K901994, sponsored by Rosofsky & Ross, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-07-31.
- Submission: K901994
- Applicant / Sponsor: Rosofsky & Ross, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1990-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EFW and 21 CFR 872.6855, within the Dental review panel as a Class I device.