Clearance Summary
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM received FDA 510(k) clearance under submission number K133706, sponsored by Zl Microdent-Attachment GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-08-21.
- Submission: K133706
- Applicant / Sponsor: Zl Microdent-Attachment GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2014-08-21
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.