Clearance Summary
PERIOGARD(R) PERIOPEN received FDA 510(k) clearance under submission number K901955, sponsored by Colgate-Palmolive Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-04-15.
- Submission: K901955
- Applicant / Sponsor: Colgate-Palmolive Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1991-04-15
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.