Clearance Summary
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE received FDA 510(k) clearance under submission number K100539, sponsored by Preventive Technologies, 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 2010-06-17.
- Submission: K100539
- Applicant / Sponsor: Preventive Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 2010-06-17
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.