Clearance Summary
FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE received FDA 510(k) clearance under submission number K945847, sponsored by Friatec Medical Inc., USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-03-15.
- Submission: K945847
- Applicant / Sponsor: Friatec Medical Inc., USA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1996-03-15
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.