Clearance Summary
DOWN PAK received FDA 510(k) clearance under submission number K070246, sponsored by Endo Twinn B.V.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-02-16.
- Submission: K070246
- Applicant / Sponsor: Endo Twinn B.V.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3850
- Decision date: 2007-02-16
Classification & Regulation
This clearance is catalogued under FDA product code EKM and 21 CFR 872.3850, within the Dental review panel as a Class I device.