Clearance Summary
I.FLEX BY TCS received FDA 510(k) clearance under submission number K123396, sponsored by Thermoplastic Comfort Systems, 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 2013-01-10.
- Submission: K123396
- Applicant / Sponsor: Thermoplastic Comfort Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2013-01-10
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.