Clearance Summary
WIRED MOUTH PROTECTOR (WMP) received FDA 510(k) clearance under submission number K131396, sponsored by Elba Laboratories, 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 2013-09-30.
- Submission: K131396
- Applicant / Sponsor: Elba Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6890
- Decision date: 2013-09-30
Classification & Regulation
This clearance is catalogued under FDA product code PFL and 21 CFR 872.6890, within the Dental review panel as a Class I device.