Clearance Summary
PERIO PROTECT TRAY received FDA 510(k) clearance under submission number K031809, sponsored by Perio Protect, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-01-23.
- Submission: K031809
- Applicant / Sponsor: Perio Protect, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6870
- Decision date: 2004-01-23
Classification & Regulation
This clearance is catalogued under FDA product code KMT and 21 CFR 872.6870, within the Dental review panel as a Class I device.