Clearance Summary
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 received FDA 510(k) clearance under submission number K033699, sponsored by Zest Anchors, 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 2004-04-22.
- Submission: K033699
- Applicant / Sponsor: Zest Anchors, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2004-04-22
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.