Clearance Summary
PROCLUDE received FDA 510(k) clearance under submission number K002989, sponsored by Ortek Therapeutics, 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 2000-12-14.
- Submission: K002989
- Applicant / Sponsor: Ortek Therapeutics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 2000-12-14
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.