Clearance Summary
SWIRL PROPHYLAXIS PASTE received FDA 510(k) clearance under submission number K903986, sponsored by Bio-Medica Concepts. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-03-28.
- Submission: K903986
- Applicant / Sponsor: Bio-Medica Concepts
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 1991-03-28
Classification & Regulation
This clearance is catalogued under FDA product code EJR and 21 CFR 872.6030, within the Dental review panel as a Class I device.