Clearance Summary
MIS CREST WIDENER received FDA 510(k) clearance under submission number K080458, sponsored by Mis - Implant Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-12-17.
- Submission: K080458
- Applicant / Sponsor: Mis - Implant Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4760
- Decision date: 2008-12-17
Classification & Regulation
This clearance is catalogued under FDA product code MQN and 21 CFR 872.4760, within the Dental review panel as a Class II device.