Clearance Summary
RELINE-IT MODEL RELINE-IT received FDA 510(k) clearance under submission number K101771, sponsored by Majestic Drug Co., 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 2010-09-20.
- Submission: K101771
- Applicant / Sponsor: Majestic Drug Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3560
- Decision date: 2010-09-20
Classification & Regulation
This clearance is catalogued under FDA product code EBP and 21 CFR 872.3560, within the Dental review panel as a Class II device.