Clearance Summary
RETRACTOFOAM received FDA 510(k) clearance under submission number K050013, sponsored by Coltene/Whaledent AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-02-09.
- Submission: K050013
- Applicant / Sponsor: Coltene/Whaledent AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2005-02-09
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.