Clearance Summary
Locator Overdenture Implant System received FDA 510(k) clearance under submission number K203701, sponsored by Ivory Super Holdco Inc. / Zest Anchors, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-04-15.
- Submission: K203701
- Applicant / Sponsor: Ivory Super Holdco Inc. / Zest Anchors, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2021-04-15
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.