Clearance Summary
BUTLER GUM PROPHY PASTE WITH NOVAMIN received FDA 510(k) clearance under submission number K024343, sponsored by Usbiomaterials Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-07-11.
- Submission: K024343
- Applicant / Sponsor: Usbiomaterials Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 2003-07-11
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.