Clearance Summary
HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE received FDA 510(k) clearance under submission number K850014, sponsored by Medi-Dent American, 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 1985-01-23.
- Submission: K850014
- Applicant / Sponsor: Medi-Dent American, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3670
- Decision date: 1985-01-23
Classification & Regulation
This clearance is catalogued under FDA product code EBH and 21 CFR 872.3670, within the Dental review panel as a Class I device.