Clearance Summary
LED PRO SEAL received FDA 510(k) clearance under submission number K073243, sponsored by Reliance Orthodontic Products, 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 2008-02-08.
- Submission: K073243
- Applicant / Sponsor: Reliance Orthodontic Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3310
- Decision date: 2008-02-08
Classification & Regulation
This clearance is catalogued under FDA product code EBD and 21 CFR 872.3310, within the Dental review panel as a Class II device.