Clearance Summary
SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) received FDA 510(k) clearance under submission number K032454, sponsored by Bio-Lok Intl., 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 2004-03-04.
- Submission: K032454
- Applicant / Sponsor: Bio-Lok Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2004-03-04
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.